Trial Outcomes & Findings for Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes (NCT NCT00841087)
NCT ID: NCT00841087
Last Updated: 2017-03-03
Results Overview
Observed 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
65 participants
Week 0 to Week 6 + 5 days follow up
2017-03-03
Participant Flow
A total of 8 sites in Japan
The period between the Visit 1 (screening visit) and Visit 2 (baseline visit) of 3 weeks \[±7 days\] was the run-in period. The subjects continued their insulin treatment (basal-bolus therapy: insulin glargine or neutral protamine Hagedorn (intermediate-acting insulin) \[NPH\] insulin) same as their pre-trial dose.
Participant milestones
| Measure |
SIBA
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
7.39 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.86 • n=5 Participants
|
7.32 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.86 • n=7 Participants
|
7.35 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.86 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
181.8 mg/dL
STANDARD_DEVIATION 66.2 • n=5 Participants
|
141.8 mg/dL
STANDARD_DEVIATION 54.3 • n=7 Participants
|
162.1 mg/dL
STANDARD_DEVIATION 63.4 • n=5 Participants
|
|
Body weight
|
64.15 kg
STANDARD_DEVIATION 11.11 • n=5 Participants
|
62.28 kg
STANDARD_DEVIATION 7.85 • n=7 Participants
|
63.23 kg
STANDARD_DEVIATION 9.61 • 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.
Observed 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 |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day 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
|
62.97 Episodes /year of patient exposure
|
80.84 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.
Observed 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 23:00-05:59 (both inclusive).
Outcome measures
| Measure |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day 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
|
4.97 Episodes /year of patient exposure
|
15.83 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 |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (AEs)
Adverse events (AEs)
|
13 events
|
15 events
|
|
Number of Treatment Emergent Adverse Events (AEs)
Serious AEs
|
0 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
|
0 events
|
2 events
|
|
Number of Treatment Emergent Adverse Events (AEs)
Mild AEs
|
13 events
|
13 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.
Observed change from baseline in body weight after 6 weeks of treatment
Outcome measures
| Measure |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Change in Body Weight
|
0.22 kg
Standard Deviation 1.02
|
-0.20 kg
Standard Deviation 1.19
|
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.
The number of subjects having a 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 |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Electrocardiogram (ECG)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
Mean values at baseline (Week 0) and at Week 6
Outcome measures
| Measure |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Diastolic Blood Pressure (BP)
Week 0 (Baseline)
|
73.9 mmHg
Standard Deviation 7.8
|
73.8 mmHg
Standard Deviation 9.3
|
|
Diastolic Blood Pressure (BP)
Week 6
|
74.7 mmHg
Standard Deviation 6.4
|
73.0 mmHg
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Week 0, Week 6Population: Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
Mean values at baseline (Week 0) and at Week 6
Outcome measures
| Measure |
SIBA
n=33 Participants
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 Participants
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Systolic Blood Pressure (BP)
Week 0 (Baseline)
|
125.0 mmHg
Standard Deviation 15.5
|
125.3 mmHg
Standard Deviation 16.0
|
|
Systolic Blood Pressure (BP)
Week 6
|
125.5 mmHg
Standard Deviation 13.3
|
120.2 mmHg
Standard Deviation 13.8
|
Adverse Events
SIBA
Insulin Detemir
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SIBA
n=33 participants at risk
Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
Insulin Detemir
n=32 participants at risk
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.2%
5/33 • Number of events 5 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up
The Safety analysis set included all subjects who were randomised and 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 were randomised and received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33 • The adverse events were collected in a time frame of 6 weeks + 5 days follow up
The Safety analysis set included all subjects who were randomised and received at least one dose of the investigational product or its comparator.
|
6.2%
2/32 • 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 were randomised and 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