Trial Outcomes & Findings for Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (NCT NCT01680341)
NCT ID: NCT01680341
Last Updated: 2018-04-02
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
272 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2018-04-02
Participant Flow
The trial was conducted in 43 sites in 5 countries: Algeria (3 sites), Germany (5 sites), Malaysia (3 sites), Turkey (3 sites), and United States (29 sites).
While entering the treatment period the subjects discontinued insulin glargine (IGlar) and sulfonylurea (SU)/glinides (if administered) but continued treatment with up to 3 other oral antidiabetic drugs (OADs) as prescribed.
Participant milestones
| Measure |
IDegAsp Simple
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
136
|
|
Overall Study
Exposed
|
135
|
134
|
|
Overall Study
COMPLETED
|
115
|
119
|
|
Overall Study
NOT COMPLETED
|
21
|
17
|
Reasons for withdrawal
| Measure |
IDegAsp Simple
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Unclassified
|
18
|
15
|
Baseline Characteristics
Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine
Baseline characteristics by cohort
| Measure |
IDegAsp Simple
n=136 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=136 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
59.1 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
58.9 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Glycosylated Haemoglobin (HbA1c)
|
8.2 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=99 Participants
|
8.2 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=107 Participants
|
8.2 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=206 Participants
|
|
Fasting plasma glucose
|
7.8 mmol/L
STANDARD_DEVIATION 2.3 • n=99 Participants
|
8.1 mmol/L
STANDARD_DEVIATION 3.0 • n=107 Participants
|
8.0 mmol/L
STANDARD_DEVIATION 2.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).
Change from baseline in HbA1c after 26 weeks of treatment.
Outcome measures
| Measure |
IDegAsp Simple
n=136 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=136 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
|
-1.45 Percent (%) glycosylated haemoglobin
Standard Error 0.09
|
-1.33 Percent (%) glycosylated haemoglobin
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.
Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment
Outcome measures
| Measure |
IDegAsp Simple
n=136 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=136 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-1.68 mmol/L
Standard Error 0.23
|
-1.98 mmol/L
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Week 26Population: The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.
Number of subjects with HbA1c below 7% after 26 weeks of treatment.
Outcome measures
| Measure |
IDegAsp Simple
n=136 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=136 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Subjects With HbA1c Below 7.0%
|
91 Subjects
|
85 Subjects
|
SECONDARY outcome
Timeframe: Week 26Population: The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Twenty five (25) subjects did not contribute to statistical analysis as Endpoint was only defined for subjects exposed for at least 12 treatment weeks.
Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.
Outcome measures
| Measure |
IDegAsp Simple
n=122 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=125 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia
|
25.4 percentage of subjects
|
32.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 0-28Population: The safety analysis set included all subjects who received at least one dose of the investigational product.
A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Outcome measures
| Measure |
IDegAsp Simple
n=135 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=134 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
|
242 number of events
|
286 number of events
|
SECONDARY outcome
Timeframe: Weeks 0-27Population: The safety analysis set included all subjects who received at least one dose of the investigational product.
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Outcome measures
| Measure |
IDegAsp Simple
n=135 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=134 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
|
552 episodes
|
323 episodes
|
SECONDARY outcome
Timeframe: From week 16 to end of trial including follow-up (week 27)Population: The safety analysis set included all subjects who received at least one dose of the investigational product. Subjects in maintenance period were included in this analysis.
Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up \[Week 27\]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Outcome measures
| Measure |
IDegAsp Simple
n=121 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=124 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
|
230 episodes
|
143 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-27Population: The safety analysis set included all subjects who received at least one dose of the investigational product.
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.
Outcome measures
| Measure |
IDegAsp Simple
n=135 Participants
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=134 Participants
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
|
82 episodes
|
49 episodes
|
Adverse Events
IDegAsp Simple
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
IDegAsp Step Wise
Serious events: 10 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegAsp Simple
n=135 participants at risk
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=134 participants at risk
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Cardiac disorders
Coronary artery disease
|
0.74%
1/135 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.74%
1/135 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.00%
0/134 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Infections and infestations
Abscess limb
|
0.74%
1/135 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.00%
0/134 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
2/135 • Number of events 2 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.00%
0/134 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.74%
1/135 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.00%
0/134 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.74%
1/135 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.00%
0/134 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Vascular disorders
Hypertension
|
0.00%
0/135 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
0.75%
1/134 • Number of events 1 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
Other adverse events
| Measure |
IDegAsp Simple
n=135 participants at risk
Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
|
IDegAsp Step Wise
n=134 participants at risk
IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
5/135 • Number of events 7 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
6.0%
8/134 • Number of events 12 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Infections and infestations
Bronchitis
|
4.4%
6/135 • Number of events 6 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
5.2%
7/134 • Number of events 7 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Infections and infestations
Influenza
|
3.7%
5/135 • Number of events 5 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
9.0%
12/134 • Number of events 12 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
12/135 • Number of events 16 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
14.9%
20/134 • Number of events 23 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
14/135 • Number of events 16 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
7.5%
10/134 • Number of events 12 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
6/135 • Number of events 6 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
6.0%
8/134 • Number of events 9 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
|
Nervous system disorders
Headache
|
6.7%
9/135 • Number of events 10 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
6.0%
8/134 • Number of events 8 • The adverse events were collected from week 0 to Week 28.
The safety analysis set included all subjects who received at least one dose of the investigational product.
|
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