Trial Outcomes & Findings for Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone (NCT NCT01215435)
NCT ID: NCT01215435
Last Updated: 2014-10-30
Results Overview
Estimated mean change from baseline in HbA1c after 11 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
245 participants
Primary outcome timeframe
Week 0, Week 11
Results posted on
2014-10-30
Participant Flow
The trial was conducted at 5 sites in Iran
Subjects were on a stable antidiabetic regimen which includes a minimum of 2 OADs, daily for at least 3 months prior to screening. OAD doses were at least 50 percent of the maximum recommended dose.
Participant milestones
| Measure |
Pre-breakfast BIAsp 30
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
123
|
|
Overall Study
COMPLETED
|
103
|
107
|
|
Overall Study
NOT COMPLETED
|
19
|
16
|
Reasons for withdrawal
| Measure |
Pre-breakfast BIAsp 30
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal Criteria
|
8
|
11
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Unclassified
|
5
|
5
|
Baseline Characteristics
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
Baseline characteristics by cohort
| Measure |
Pre-breakfast BIAsp 30
n=122 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
n=123 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.32 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
9.1 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.07 • n=5 Participants
|
9.2 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.00 • n=7 Participants
|
9.2 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.04 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
192.7 mg/dL
STANDARD_DEVIATION 68.56 • n=5 Participants
|
199.3 mg/dL
STANDARD_DEVIATION 63.80 • n=7 Participants
|
196.0 mg/dL
STANDARD_DEVIATION 66.16 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 11Population: Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF)
Estimated mean change from baseline in HbA1c after 11 weeks of treatment
Outcome measures
| Measure |
Pre-breakfast BIAsp 30
n=122 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
n=123 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
|
-1.04 percentage of glycosylated haemoglobin
Standard Error 0.10
|
-0.90 percentage of glycosylated haemoglobin
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Week 0, Week 36Population: Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
Estimated mean change from baseline in FPG after 36 weeks of treatment
Outcome measures
| Measure |
Pre-breakfast BIAsp 30
n=122 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
n=123 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
|---|---|---|
|
Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
|
-61.57 mg/dL
Standard Deviation 4.50
|
-58.43 mg/dL
Standard Deviation 4.48
|
SECONDARY outcome
Timeframe: Week 0 to Week 36Population: Safety analysis set includes all subjects who received at least one dose of the trial product.
A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.
Outcome measures
| Measure |
Pre-breakfast BIAsp 30
n=122 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
n=123 Participants
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes
|
1181 episodes
|
953 episodes
|
Adverse Events
Pre-breakfast BIAsp 30
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Pre-dinner BIAsp 30
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-breakfast BIAsp 30
n=122 participants at risk
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
n=123 participants at risk
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
1.6%
2/122 • Number of events 2 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
0.00%
0/123 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
|
Cardiac disorders
Coronary artery disease
|
0.82%
1/122 • Number of events 1 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
0.81%
1/123 • Number of events 1 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/122 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
0.81%
1/123 • Number of events 1 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/122 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
0.81%
1/123 • Number of events 1 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/122 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
0.81%
1/123 • Number of events 1 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
Other adverse events
| Measure |
Pre-breakfast BIAsp 30
n=122 participants at risk
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
Pre-dinner BIAsp 30
n=123 participants at risk
Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.7%
7/122 • Number of events 8 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
6.5%
8/123 • Number of events 13 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.4%
9/122 • Number of events 9 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial product.
|
8.9%
11/123 • Number of events 11 • The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.
Safety analysis set includes all subjects who received at least one dose of the trial 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.
- Publication restrictions are in place
Restriction type: OTHER