Trial Outcomes & Findings for Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (NCT NCT01618214)
NCT ID: NCT01618214
Last Updated: 2017-02-24
Results Overview
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
344 participants
Primary outcome timeframe
Week 0, week 20
Results posted on
2017-02-24
Participant Flow
Subjects were recruited from 23 sites in 1 country.
Eligible subjects were randomised in a 1:1 manner to one of the 2 treatment groups.
Participant milestones
| Measure |
Subject-driven Titration
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
172
|
|
Overall Study
Exposed
|
172
|
172
|
|
Overall Study
COMPLETED
|
162
|
159
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
| Measure |
Subject-driven Titration
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Withdrawal Criteria
|
1
|
2
|
|
Overall Study
Unclassified
|
4
|
5
|
Baseline Characteristics
Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Subject-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
53.4 years
STANDARD_DEVIATION 7.5 • n=107 Participants
|
54.1 years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Gender
Female
|
79 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Gender
Male
|
93 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
172 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
344 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Weight
|
70.3 kg
STANDARD_DEVIATION 11.3 • n=99 Participants
|
69.5 kg
STANDARD_DEVIATION 11.6 • n=107 Participants
|
69.9 kg
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Body mass index (BMI)
|
25.76 kg/m^2
STANDARD_DEVIATION 3.26 • n=99 Participants
|
25.47 kg/m^2
STANDARD_DEVIATION 3.01 • n=107 Participants
|
25.62 kg/m^2
STANDARD_DEVIATION 3.14 • n=206 Participants
|
|
Glycosylated Haemoglobin (HbA1c)
|
8.10 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.64 • n=99 Participants
|
8.14 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.67 • n=107 Participants
|
8.12 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.65 • n=206 Participants
|
|
Fasting Plasma Glucose
|
8.83 mmol/L
STANDARD_DEVIATION 2.36 • n=99 Participants
|
9.07 mmol/L
STANDARD_DEVIATION 2.43 • n=107 Participants
|
8.95 mmol/L
STANDARD_DEVIATION 2.40 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) - included all randomised subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomisation measurements were available. Six subjects did not contribute to FAS due to lack of post-randomisation measurements.
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Outcome measures
| Measure |
Subject-driven Titration
n=168 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=170 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
|
-1.32 percentage of glycosylated haemoglobin
Standard Deviation 0.86
|
-1.31 percentage of glycosylated haemoglobin
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: After 20 weeks of treatmentPopulation: Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.
Outcome measures
| Measure |
Subject-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Below 7.0%
|
64.5 percentage (%) of subjects
|
58.1 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: After 20 weeks of treatmentPopulation: Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.
Outcome measures
| Measure |
Subject-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
|
35.5 percentage (%) of subjects
|
37.2 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. Seven subjects did not contribute to FAS due to lack of post-randomization measurements.
Outcome measures
| Measure |
Subject-driven Titration
n=168 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=169 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Change From Baseline in FPG (Fasting Plasma Glucose)
|
-1.26 mmol/L
Standard Deviation 2.59
|
-1.48 mmol/L
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Week 0 to week 20 (inclusive).Population: Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value \< 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.
Outcome measures
| Measure |
Subject-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=172 Participants
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
All hypoglycemic events
|
10.04 events per patient per year
|
10.90 events per patient per year
|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Severe hypoglycemic events
|
0.02 events per patient per year
|
0.02 events per patient per year
|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Minor hypoglycemic events
|
1.70 events per patient per year
|
1.66 events per patient per year
|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Probable symptomatic hypoglycemia
|
0.45 events per patient per year
|
0.56 events per patient per year
|
Adverse Events
Subject-driven Titration
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Investigator-driven Titration
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subject-driven Titration
n=172 participants at risk
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=172 participants at risk
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Cardiac disorders
Coronary artery disease
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Ear and labyrinth disorders
Meniere
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
|
Vascular disorders
Hypertension
|
0.00%
0/172 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
Other adverse events
| Measure |
Subject-driven Titration
n=172 participants at risk
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period \[4 weeks\] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period \[16 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
Investigator-driven Titration
n=172 participants at risk
Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period \[20 weeks\]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.58%
1/172 • Number of events 1 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
7.6%
13/172 • Number of events 15 • The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.
Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.
|
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. Novo Nordisk reserves the right to prior review of such publications and to ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.
- Publication restrictions are in place
Restriction type: OTHER