Trial Outcomes & Findings for Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756 (NCT NCT01278160)
NCT ID: NCT01278160
Last Updated: 2014-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
179 participants
Primary outcome timeframe
Week 0, week 16
Results posted on
2014-10-27
Participant Flow
This trial was conducted at 20 sites in China.
All subjects who completed the 24 week treatment and did not achieve the target of glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIAsp-3756 (NCT01123980) were offered the possibility to go into BIAsp-3883. Subjects continued their previous treatment unchanged from trial BIASP-3756 and throughout the one-week screening period.
Participant milestones
| Measure |
BIAsp 30 (2:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
90
|
|
Overall Study
COMPLETED
|
84
|
84
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
BIAsp 30 (2:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Unclassified
|
1
|
2
|
Baseline Characteristics
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756
Baseline characteristics by cohort
| Measure |
BIAsp 30 (2:1)
n=89 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
n=90 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
57.1 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
56.1 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
84 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
|
89 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
179 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
|
|
Region of Enrollment
China
|
89 participants
n=99 Participants
|
90 participants
n=107 Participants
|
179 participants
n=206 Participants
|
|
Height
|
165.2 cm
STANDARD_DEVIATION 7.4 • n=99 Participants
|
165.3 cm
STANDARD_DEVIATION 8.4 • n=107 Participants
|
165.3 cm
STANDARD_DEVIATION 7.9 • n=206 Participants
|
|
Weight
|
72.2 kg
STANDARD_DEVIATION 11.1 • n=99 Participants
|
72.3 kg
STANDARD_DEVIATION 11.6 • n=107 Participants
|
72.2 kg
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Body mass index (BMI)
|
26.40 kg/m^2
STANDARD_DEVIATION 3.44 • n=99 Participants
|
26.36 kg/m^2
STANDARD_DEVIATION 3.28 • n=107 Participants
|
26.38 kg/m^2
STANDARD_DEVIATION 3.35 • n=206 Participants
|
|
Glycosylated haemoglobin (HbA1c) at screening
|
7.80 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.65 • n=99 Participants
|
7.80 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.73 • n=107 Participants
|
7.80 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.69 • n=206 Participants
|
|
Duration of diabetes
|
9.08 years
STANDARD_DEVIATION 6.05 • n=99 Participants
|
10.23 years
STANDARD_DEVIATION 5.89 • n=107 Participants
|
9.65 years
STANDARD_DEVIATION 5.98 • n=206 Participants
|
|
Diabetic complications
Yes
|
16 participants
n=99 Participants
|
22 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Diabetic complications
No
|
69 participants
n=99 Participants
|
67 participants
n=107 Participants
|
136 participants
n=206 Participants
|
|
Diabetic complications
Missing data
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 16Population: Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). Six patients discontinued trial without any post randomisation HbA1c measurements.
Outcome measures
| Measure |
BIAsp 30 (2:1)
n=86 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
n=87 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
|
-0.13 percentage of glycosylated haemoglobin
Standard Deviation 0.08
|
-0.12 percentage of glycosylated haemoglobin
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).
A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day
Outcome measures
| Measure |
BIAsp 30 (2:1)
n=89 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
n=90 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
Before breakfast
|
6.02 mmol/L
Standard Error 1.09
|
6.23 mmol/L
Standard Error 1.23
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
2 hours after breakfast
|
8.56 mmol/L
Standard Error 2.28
|
8.61 mmol/L
Standard Error 2.41
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
Before lunch
|
6.42 mmol/L
Standard Error 1.62
|
6.79 mmol/L
Standard Error 2.49
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
2 hours after lunch
|
8.91 mmol/L
Standard Error 2.59
|
9.17 mmol/L
Standard Error 2.70
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
Before dinner
|
6.64 mmol/L
Standard Error 1.95
|
7.07 mmol/L
Standard Error 2.07
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
2 hours after dinner
|
7.92 mmol/L
Standard Error 2.34
|
7.94 mmol/L
Standard Error 1.98
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
Bedtime
|
7.29 mmol/L
Standard Error 1.99
|
7.03 mmol/L
Standard Error 1.91
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
2:00 - 4:00 a.m.
|
6.05 mmol/L
Standard Error 1.53
|
6.34 mmol/L
Standard Error 1.65
|
|
9-point SMPG (Self Measured Plasma Glucose) Profile
Before breakfast the following day
|
6.30 mmol/L
Standard Error 1.38
|
6.22 mmol/L
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).
The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment
Outcome measures
| Measure |
BIAsp 30 (2:1)
n=89 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
n=90 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Below 7.0%
|
12.4 percentage of subjects
|
14.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).
The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment
Outcome measures
| Measure |
BIAsp 30 (2:1)
n=89 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
n=90 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
|
2.2 percentage of subjects
|
7.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 0-16Population: Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).
Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).
Outcome measures
| Measure |
BIAsp 30 (2:1)
n=89 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
n=90 Participants
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes
All episodes
|
108 episodes
|
143 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Nocturnal
|
18 episodes
|
11 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Diurnal
|
84 episodes
|
127 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Severe
|
0 episodes
|
0 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Minor
|
20 episodes
|
35 episodes
|
Adverse Events
BIAsp 30 (2:1)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
BIAsp 30 (1:1)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIAsp 30 (2:1)
n=89 participants at risk
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
BIAsp 30 (1:1)
n=90 participants at risk
After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
|
|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/89 • Number of events 1 • The adverse events were collected in a timespan of 17 weeks.
The safety analysis set contained all subjects exposed to at least one dose of investigational products.
|
0.00%
0/90 • The adverse events were collected in a timespan of 17 weeks.
The safety analysis set contained all subjects exposed to at least one dose of investigational products.
|
|
Infections and infestations
Viral infection
|
0.00%
0/89 • The adverse events were collected in a timespan of 17 weeks.
The safety analysis set contained all subjects exposed to at least one dose of investigational products.
|
1.1%
1/90 • Number of events 1 • The adverse events were collected in a timespan of 17 weeks.
The safety analysis set contained all subjects exposed to at least one dose of investigational products.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/89 • The adverse events were collected in a timespan of 17 weeks.
The safety analysis set contained all subjects exposed to at least one dose of investigational products.
|
1.1%
1/90 • Number of events 1 • The adverse events were collected in a timespan of 17 weeks.
The safety analysis set contained all subjects exposed to at least one dose of investigational products.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right to not release data until specified milestones, e.g. when the clinical trial report is available. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER