Trial Outcomes & Findings for Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus (NCT NCT00842361)
NCT ID: NCT00842361
Last Updated: 2017-02-09
Results Overview
Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
COMPLETED
PHASE2
66 participants
Week 0 to Week 6 + 5 days follow up
2017-02-09
Participant Flow
A total of 8 sites in Japan
Participant milestones
| Measure |
SIAC
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
Exposed
|
33
|
32
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
SIAC
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Unclassified
|
0
|
2
|
Baseline Characteristics
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Gender
Male
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
7.36 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.86 • n=5 Participants
|
7.44 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.84 • n=7 Participants
|
7.40 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
144.6 mg/L
STANDARD_DEVIATION 36.4 • n=5 Participants
|
140.8 mg/L
STANDARD_DEVIATION 38.6 • n=7 Participants
|
142.7 mg/L
STANDARD_DEVIATION 37.3 • n=5 Participants
|
|
Body weight
|
61.22 kg
STANDARD_DEVIATION 9.88 • n=5 Participants
|
57.32 kg
STANDARD_DEVIATION 7.94 • n=7 Participants
|
59.30 kg
STANDARD_DEVIATION 9.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 6 + 5 days follow upPopulation: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
Outcome measures
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Rate of Major and Minor Hypoglycaemic Episodes
Major
|
0 Episodes /year of patient exposure
|
0 Episodes /year of patient exposure
|
|
Rate of Major and Minor Hypoglycaemic Episodes
Minor
|
13.63 Episodes /year of patient exposure
|
21.83 Episodes /year of patient exposure
|
PRIMARY outcome
Timeframe: Week 0 to Week 6 + 5 days follow upPopulation: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).
Outcome measures
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Major
|
0 Episodes /year of patient exposure
|
0 Episodes /year of patient exposure
|
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Minor
|
0.99 Episodes /year of patient exposure
|
2.03 Episodes /year of patient exposure
|
SECONDARY outcome
Timeframe: Week 0 to Week 6 + 5 days follow upPopulation: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Outcome measures
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (AEs)
Adverse events (AEs)
|
13 events
|
8 events
|
|
Number of Treatment Emergent Adverse Events (AEs)
Serious AEs
|
1 events
|
0 events
|
|
Number of Treatment Emergent Adverse Events (AEs)
Severe AEs
|
0 events
|
0 events
|
|
Number of Treatment Emergent Adverse Events (AEs)
Moderate AEs
|
1 events
|
0 events
|
|
Number of Treatment Emergent Adverse Events (AEs)
Mild AEs
|
12 events
|
8 events
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).
Change from baseline in body weight after 6 weeks of treatment
Outcome measures
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Change in Body Weight
|
0.09 kg
Standard Deviation 0.79
|
-0.10 kg
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).
The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.
Outcome measures
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Electrocardiogram (ECG) Worsening
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).
Values at baseline (Week 0) and at Week 6
Outcome measures
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Diastolic BP (Blood Pressure)
Week 6
|
76.8 mmHg
Standard Deviation 10.4
|
76.7 mmHg
Standard Deviation 10.0
|
|
Diastolic BP (Blood Pressure)
Week 0 (Baseline)
|
77.3 mmHg
Standard Deviation 11.1
|
75.4 mmHg
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Week 0, Week 6.Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).
Values at baseline (Week 0) and at Week 6
Outcome measures
| Measure |
SIAC
n=33 Participants
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 Participants
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Systolic BP (Blood Pressure)
Week 0 (Baseline)
|
137.5 mmHg
Standard Deviation 15.5
|
130.8 mmHg
Standard Deviation 17.4
|
|
Systolic BP (Blood Pressure)
Week 6
|
137.0 mmHg
Standard Deviation 17.0
|
130.9 mmHg
Standard Deviation 16.0
|
Adverse Events
SIAC
Mix30
Serious adverse events
| Measure |
SIAC
n=33 participants at risk
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 participants at risk
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.0%
1/33 • Number of events 1 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/32 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
Other adverse events
| Measure |
SIAC
n=33 participants at risk
Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart \[IAsp\], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
|
Mix30
n=32 participants at risk
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Cardiac disorders
Supraventricular extrasystoles
|
6.1%
2/33 • Number of events 2 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/32 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
3/33 • Number of events 3 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
9.4%
3/32 • Number of events 3 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
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