Trial Outcomes & Findings for Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes (NCT NCT01486966)
NCT ID: NCT01486966
Last Updated: 2017-03-17
Results Overview
Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
Week 0, week 2
Results posted on
2017-03-17
Participant Flow
A total of 6 centres in China participated.
Between screening and treatment with trial drugs, subjects were assessed for eligibility and were randomised 1:1 into one of the two treatment arms.
Participant milestones
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=29 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
56.7 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 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
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 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
|
|
Height
|
164.2 cm
STANDARD_DEVIATION 8.5 • n=99 Participants
|
164.2 cm
STANDARD_DEVIATION 8.4 • n=107 Participants
|
164.2 cm
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Weight
|
70.9 kg
STANDARD_DEVIATION 13.1 • n=99 Participants
|
66.5 kg
STANDARD_DEVIATION 9.0 • n=107 Participants
|
68.7 kg
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Body mass index (BMI)
|
26.09 kg/m^2
STANDARD_DEVIATION 3.13 • n=99 Participants
|
24.63 kg/m^2
STANDARD_DEVIATION 2.67 • n=107 Participants
|
25.36 kg/m^2
STANDARD_DEVIATION 2.98 • n=206 Participants
|
|
Pre-trial treatment of oral antidiabetic drug
Acarbose
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Pre-trial treatment of oral antidiabetic drug
Gliclazide
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Pre-trial treatment of oral antidiabetic drug
Glimepiride
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Pre-trial treatment of oral antidiabetic drug
Metformin
|
13 participants
n=99 Participants
|
8 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Pre-trial treatment of oral antidiabetic drug
Metformin hydrochloride
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Pre-trial treatment of oral antidiabetic drug
Repaglinide
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Pre-trial insulin treatment
basal insulin (once daily)
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Pre-trial insulin treatment
premixed insulin (twice daily)
|
23 participants
n=99 Participants
|
22 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Glycosylated haemoglobin A1c (HbA1c)
|
8.76 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.73 • n=99 Participants
|
8.49 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.76 • n=107 Participants
|
8.62 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.75 • n=206 Participants
|
|
Type 2 diabetes
|
29 participants
n=99 Participants
|
29 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Duration of diagnosed diabetes
|
10.23 years
STANDARD_DEVIATION 5.08 • n=99 Participants
|
11.97 years
STANDARD_DEVIATION 7.14 • n=107 Participants
|
11.10 years
STANDARD_DEVIATION 6.20 • n=206 Participants
|
|
Diabetes complications
Diabetic complications
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Diabetes complications
Diabetic retinopathy
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Diabetes complications
Diabetic neuropathy
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Diabetes complications
Diabetic Nephropathy
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Diabetes complications
Macroangiopathy
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.
Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=27 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
|
-2.84 mmol/L
Standard Error 0.27
|
-2.80 mmol/L
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Week 0, week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.
The FPG referred to pre-breakfast plasma glucose.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=27 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
|
-2.22 mmol/L
Standard Error 0.34
|
-2.29 mmol/L
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Week 0, week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.
The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=27 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment
|
-4.00 mmol/L
Standard Error 0.39
|
-3.47 mmol/L
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Week 0, week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.
The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=27 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment
|
-2.47 mmol/L
Standard Error 0.38
|
-2.87 mmol/L
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=29 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
|
48.3 percentage (%) of subjects
|
48.3 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=29 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
|
41.4 percentage (%) of subjects
|
34.5 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.
FPG target was \< 6.0 mmol / L, 2hPPG target was \< 8.0 mmol / L.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=29 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment
|
20.7 percentage (%) of subjects
|
20.7 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.
FPG target was \< 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=29 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment
|
41.4 percentage (%) of subjects
|
34.5 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Week 0, week 2Population: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=27 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Change From Baseline in Fructosamine After Two Weeks of Treatment
|
-31.0 Umol/L
Standard Error 5.37
|
-23.7 Umol/L
Standard Error 5.50
|
SECONDARY outcome
Timeframe: Weeks 0-2Population: Safety analysis set included all subjects receiving at least one dose of the trial products.
All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition. Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) \< 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value \< 3.1 mmol/l (56 mg/dl). A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal.
Outcome measures
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 Participants
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=29 Participants
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Incidence of Hypoglycaemic Episodes
All events
|
22 events
|
54 events
|
|
Incidence of Hypoglycaemic Episodes
Severe
|
0 events
|
0 events
|
|
Incidence of Hypoglycaemic Episodes
Nocturnal
|
4 events
|
11 events
|
|
Incidence of Hypoglycaemic Episodes
Diurnal
|
18 events
|
43 events
|
|
Incidence of Hypoglycaemic Episodes
Minor
|
2 events
|
11 events
|
Adverse Events
Insulin Detemir + Insulin Aspart ± Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin NPH + Human Soluble Insulin ± Metformin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Detemir + Insulin Aspart ± Metformin
n=29 participants at risk
Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0\~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
Insulin NPH + Human Soluble Insulin ± Metformin
n=29 participants at risk
Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
|
|---|---|---|
|
Infections and infestations
upper restiratory tract infection
|
0.00%
0/29 • The adverse events were collected in a timeframe of 2 weeks.
Safety analysis set included all subjects receiving at least one dose of the trial products. All adverse events summarised were treatment emergent adverse events.
|
6.9%
2/29 • Number of events 2 • The adverse events were collected in a timeframe of 2 weeks.
Safety analysis set included all subjects receiving at least one dose of the trial products. All adverse events summarised were treatment emergent adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right to not release data until specified milestones, for example, 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