Trial Outcomes & Findings for A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes (NCT NCT01880736)
NCT ID: NCT01880736
Last Updated: 2017-02-10
Results Overview
Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
458 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2017-02-10
Participant Flow
The trial was conducted at 39 sites in Japan.
Pre-assignment: Subjects switched from their pre-trial IGlar to IDeg unit-to-unit and continued pre-trial OADs (maximum of 3) at unchanged doses and frequency.
Participant milestones
| Measure |
IDeg OD Fixed Dosing and Simple Titration (Arm A)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
|
IDeg OD Fixed Dosing and Stepwise Titration (Arm B)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
|
IDeg OD Flexible Dosing and Simple Titration (Arm C)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
|
IDeg OD Flexible Dosing and Stepwise Titration (Arm D)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
114
|
115
|
115
|
114
|
|
Overall Study
COMPLETED
|
113
|
113
|
114
|
108
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
6
|
Reasons for withdrawal
| Measure |
IDeg OD Fixed Dosing and Simple Titration (Arm A)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
|
IDeg OD Fixed Dosing and Stepwise Titration (Arm B)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
|
IDeg OD Flexible Dosing and Simple Titration (Arm C)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
|
IDeg OD Flexible Dosing and Stepwise Titration (Arm D)
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal Criteria
|
1
|
2
|
1
|
5
|
Baseline Characteristics
A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDeg OD Fixed Dosing and Simple Titration (Arm A)
n=114 Participants
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
|
IDeg OD Fixed Dosing and Stepwise Titration (Arm B)
n=115 Participants
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
|
IDeg OD Flexible Dosing and Simple Titration (Arm C)
n=115 Participants
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
|
IDeg OD Flexible Dosing and Stepwise Titration (Arm D)
n=114 Participants
The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
60.7 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
60.0 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
60.2 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 10.7 • n=31 Participants
|
|
Gender
Female
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
166 Participants
n=31 Participants
|
|
Gender
Male
|
73 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
292 Participants
n=31 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
7.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=99 Participants
|
7.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=107 Participants
|
7.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.5 • n=206 Participants
|
7.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=31 Participants
|
|
Fasting plasma glucose (FPG)
|
129.8 mg/dL
STANDARD_DEVIATION 30.0 • n=99 Participants
|
136.0 mg/dL
STANDARD_DEVIATION 38.1 • n=107 Participants
|
131.8 mg/dL
STANDARD_DEVIATION 33.5 • n=206 Participants
|
134.5 mg/dL
STANDARD_DEVIATION 39.6 • n=7 Participants
|
133.0 mg/dL
STANDARD_DEVIATION 35.5 • n=31 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: The full analysis set (FAS) included all randomised subjects. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
|
-0.54 Percent (%) glycosylated haemoglobin
Standard Deviation 0.76
|
-0.62 Percent (%) glycosylated haemoglobin
Standard Deviation 0.75
|
-0.57 Percent (%) glycosylated haemoglobin
Standard Deviation 0.72
|
-0.59 Percent (%) glycosylated haemoglobin
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-28.8 mg/dL
Standard Deviation 39.0
|
-25.4 mg/dL
Standard Deviation 40.2
|
-27.0 mg/dL
Standard Deviation 35.3
|
-27.2 mg/dL
Standard Deviation 43.6
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.
The number of subjects who achieved the pre-defined HbA1c target (\<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial
|
90 Subjects
|
95 Subjects
|
91 Subjects
|
94 Subjects
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
|
150 events
|
154 events
|
138 events
|
166 events
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L \[less than 56 mg/dL\]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))
|
476 episodes
|
371 episodes
|
469 episodes
|
378 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Severe
|
0 episodes
|
1 episodes
|
1 episodes
|
0 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Documented symptomatic
|
1262 episodes
|
1141 episodes
|
1293 episodes
|
1110 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Asymptomatic
|
1523 episodes
|
1283 episodes
|
1505 episodes
|
1301 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
ADA Events Overall
|
3053 episodes
|
2736 episodes
|
3089 episodes
|
2700 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Probable symptomatic
|
87 episodes
|
131 episodes
|
103 episodes
|
115 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Relative
|
181 episodes
|
180 episodes
|
187 episodes
|
174 episodes
|
SECONDARY outcome
Timeframe: From Week 16 to end of trial (week 27)Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product. Subjects were grouped either according to dosing pattern or treatment algorithm received. 451 subjects contributed to the analysis. Subjects in the safety analysis set contributed to the evaluation "as treated".
The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=223 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=228 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=227 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=224 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
|
227 episodes
|
192 episodes
|
241 episodes
|
178 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
|
77 episodes
|
58 episodes
|
80 episodes
|
55 episodes
|
SECONDARY outcome
Timeframe: From week 16 to end of trial (week 27)Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Outcome measures
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 Participants
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period
|
34 episodes
|
23 episodes
|
40 episodes
|
17 episodes
|
Adverse Events
IDeg OD Flexible (Arm C+Arm D)
Serious events: 8 serious events
Other events: 79 other events
Deaths: 0 deaths
IDeg OD Fixed (Arm A+Arm B)
Serious events: 6 serious events
Other events: 82 other events
Deaths: 0 deaths
IDeg OD Simple (Arm A+Arm C)
Serious events: 7 serious events
Other events: 78 other events
Deaths: 0 deaths
IDeg OD Stepwise (Arm B+Arm D)
Serious events: 7 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Gastrointestinal disorders
Enterocolitis
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Infections and infestations
Cellulitis
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Infections and infestations
Pneumonia
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.87%
2/229 • Number of events 2 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Psychiatric disorders
Completed suicide
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/229 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
0.44%
1/229 • Number of events 1 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
Other adverse events
| Measure |
IDeg OD Flexible (Arm C+Arm D)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
|
IDeg OD Fixed (Arm A+Arm B)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Simple (Arm A+Arm C)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3-27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0-5.0 mmol/L or 71-90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
IDeg OD Stepwise (Arm B+Arm D)
n=229 participants at risk
The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
|
|---|---|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
10.5%
24/229 • Number of events 25 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
8.7%
20/229 • Number of events 20 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
7.9%
18/229 • Number of events 18 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
11.4%
26/229 • Number of events 27 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Infections and infestations
Nasopharyngitis
|
29.3%
67/229 • Number of events 87 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
30.1%
69/229 • Number of events 92 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
29.7%
68/229 • Number of events 90 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
29.7%
68/229 • Number of events 89 • This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation "as treated".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER