Trial Outcomes & Findings for Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs (NCT NCT00819741)
NCT ID: NCT00819741
Last Updated: 2017-02-10
Results Overview
Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
COMPLETED
PHASE4
433 participants
week -2 (screening), week 16
2017-02-10
Participant Flow
The trial was conducted at 17 sites in China.
Between screening and treatment with trial drug, subjects were assessed for eligibility and were randomised to one of two treatment arms. After start of treatment, all the subjects underwent a 6-week dose titration period followed by a 10-week maintenance period. A subgroup of 50 subjects from each treatment group was chosen.
Participant milestones
| Measure |
Repaglinide + Metformin
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
215
|
|
Overall Study
Exposed to Drug
|
218
|
214
|
|
Overall Study
COMPLETED
|
196
|
201
|
|
Overall Study
NOT COMPLETED
|
22
|
14
|
Reasons for withdrawal
| Measure |
Repaglinide + Metformin
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Unclassified
|
6
|
0
|
|
Overall Study
Reasons unknown
|
3
|
3
|
Baseline Characteristics
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
Baseline characteristics by cohort
| Measure |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
Total
n=432 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
49.4 years
STANDARD_DEVIATION 10.0 • n=107 Participants
|
49.9 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Gender
Female
|
60 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Gender
Male
|
158 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
313 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
|
218 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
432 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
|
|
BMI
|
24.50 kg/m^2
STANDARD_DEVIATION 2.97 • n=99 Participants
|
24.44 kg/m^2
STANDARD_DEVIATION 3.05 • n=107 Participants
|
24.47 kg/m^2
STANDARD_DEVIATION 3.00 • n=206 Participants
|
|
Weight
|
68.3 kg
STANDARD_DEVIATION 10.8 • n=99 Participants
|
68.2 kg
STANDARD_DEVIATION 11.0 • n=107 Participants
|
68.3 kg
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Duration of diabetes
|
0.14 months
STANDARD_DEVIATION 0.73 • n=99 Participants
|
0.28 months
STANDARD_DEVIATION 1.57 • n=107 Participants
|
0.21 months
STANDARD_DEVIATION 1.22 • n=206 Participants
|
|
HbA1c
|
10.91 percentage (%) of total haemoglobin
STANDARD_DEVIATION 1.45 • n=99 Participants
|
10.73 percentage (%) of total haemoglobin
STANDARD_DEVIATION 1.50 • n=107 Participants
|
10.82 percentage (%) of total haemoglobin
STANDARD_DEVIATION 1.48 • n=206 Participants
|
PRIMARY outcome
Timeframe: week -2 (screening), week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
Outcome measures
| Measure |
Repaglinide + Metformin
n=212 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=209 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin A1c (HbA1c)
|
-4.450 percentage (%) of total haemoglobin
Standard Error 0.070
|
-4.148 percentage (%) of total haemoglobin
Standard Error 0.071
|
SECONDARY outcome
Timeframe: week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.
Outcome measures
| Measure |
Repaglinide + Metformin
n=211 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=209 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
-4.646 mmol/L
Standard Error 0.129
|
-3.982 mmol/L
Standard Error 0.130
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment
Outcome measures
| Measure |
Repaglinide + Metformin
n=210 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=204 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in 2-hour Postprandial Plasma Glucose
|
-7.525 mmol/L
Standard Error 0.237
|
-6.794 mmol/L
Standard Error 0.242
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment.
Outcome measures
| Measure |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in 7-point Plasma Glucose Profile
Before breakfast, N=204, 199
|
-4.99 mmol/L
Standard Error 0.11
|
-4.58 mmol/L
Standard Error 0.12
|
|
Change in 7-point Plasma Glucose Profile
2 hours after breakfast, N=206, 201
|
-7.85 mmol/L
Standard Error 0.23
|
-7.40 mmol/L
Standard Error 0.24
|
|
Change in 7-point Plasma Glucose Profile
Before lunch, N=203, 200
|
-6.85 mmol/L
Standard Error 0.18
|
-6.28 mmol/L
Standard Error 0.18
|
|
Change in 7-point Plasma Glucose Profile
2 hours after lunch, N=204, 201
|
-8.00 mmol/L
Standard Error 0.21
|
-6.98 mmol/L
Standard Error 0.21
|
|
Change in 7-point Plasma Glucose Profile
Before dinner N=204, 202
|
-5.62 mmol/L
Standard Error 0.17
|
-5.09 mmol/L
Standard Error 0.17
|
|
Change in 7-point Plasma Glucose Profile
2 hours after dinner N=204, 199
|
-7.13 mmol/L
Standard Error 0.21
|
-5.70 mmol/L
Standard Error 0.22
|
|
Change in 7-point Plasma Glucose Profile
Bedtime N=195, 188
|
-6.93 mmol/L
Standard Error 0.19
|
-5.82 mmol/L
Standard Error 0.19
|
|
Change in 7-point Plasma Glucose Profile
Average N=207, 202
|
-6.78 mmol/L
Standard Error 0.14
|
-5.99 mmol/L
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.
Outcome measures
| Measure |
Repaglinide + Metformin
n=49 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=46 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in Fasting Serum Insulin
|
3.163 mU/L
Standard Error 1.801
|
5.694 mU/L
Standard Error 1.872
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.
Outcome measures
| Measure |
Repaglinide + Metformin
n=49 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=44 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in 2-hour Postprandial Serum Insulin
|
34.083 mU/L
Standard Error 6.731
|
28.548 mU/L
Standard Error 7.132
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment
Outcome measures
| Measure |
Repaglinide + Metformin
n=49 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=46 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in Fasting Serum C-peptide
|
0.041 ng/ml
Standard Error 0.123
|
0.405 ng/ml
Standard Error 0.128
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.
Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment
Outcome measures
| Measure |
Repaglinide + Metformin
n=49 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=44 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in 2-hour Postprandial Serum C-peptide
|
2.301 ng/ml
Standard Error 0.347
|
2.081 ng/ml
Standard Error 0.369
|
SECONDARY outcome
Timeframe: Weeks 0-16Population: Safety analysis set was defined as all randomised and exposed subjects.
Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Hypoglycaemic Episodes
Major
|
0 episodes
|
0 episodes
|
|
Hypoglycaemic Episodes
Minor
|
41 episodes
|
16 episodes
|
|
Hypoglycaemic Episodes
Symptoms only
|
90 episodes
|
71 episodes
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Safety analysis set was defined as all randomised and exposed subjects.
Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment
Outcome measures
| Measure |
Repaglinide + Metformin
n=196 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=201 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Change in Blood Pressure
Blood pressure diastolic
|
-1.0 mmHg
Standard Deviation 8.8
|
-0.9 mmHg
Standard Deviation 9.5
|
|
Change in Blood Pressure
Blood pressure systolic
|
-1.5 mmHg
Standard Deviation 14.3
|
-1.4 mmHg
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Week -2, week 16Population: Safety analysis set was defined as all randomised and exposed subjects.
The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen.
Outcome measures
| Measure |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Physical Examinations
|
3 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Week -2, week 16Population: Safety analysis set was defined as all randomised and exposed subjects.
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 |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
ECG (ElectroCardioGram)
|
3 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Week -2, week 16Population: Safety analysis set was defined as all randomised and exposed subjects.
The number of subjects having a change in Alanine Aminotransferase (ALAT) 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 |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Biochemistry: Alanine Aminotransferase (ALAT)
|
4 Subjects
|
5 Subjects
|
SECONDARY outcome
Timeframe: Week -2, week 16Population: Safety analysis set was defined as all randomised and exposed subjects.
The number of subjects having a change in Aspartate Aminotransferase (ASAT) 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 |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Biochemistry: Alanine Aminotransferase (ASAT)
|
2 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: Week -2, week 16Population: Safety analysis set was defined as all randomised and exposed subjects.
Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement 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 |
Repaglinide + Metformin
n=218 Participants
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 Participants
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Haematology: Haemoglobin
|
1 Subjects
|
0 Subjects
|
Adverse Events
Repaglinide + Metformin
Repaglinide
Serious adverse events
| Measure |
Repaglinide + Metformin
n=218 participants at risk
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
|
Repaglinide
n=214 participants at risk
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/218 • The adverse events were collected in a time span of 16 weeks.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial drug(s).
|
0.47%
1/214 • Number of events 1 • The adverse events were collected in a time span of 16 weeks.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial drug(s).
|
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