Trial Outcomes & Findings for Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment (NCT NCT01022762)
NCT ID: NCT01022762
Last Updated: 2014-07-09
Results Overview
COMPLETED
PHASE4
440 participants
Week 0, week 16
2014-07-09
Participant Flow
The trial was conducted at 23 sites in China.
Between screening and treatment with trial drug the participants were assessed for eligibility and were randomised to one of two treatment arms. A sub-group of 69 participants was recruited for intravenous glucose tolerance test and randomised into the repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants)
Participant milestones
| Measure |
Repaglinide
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
222
|
|
Overall Study
Exposed to Trial Drug
|
217
|
218
|
|
Overall Study
COMPLETED
|
196
|
194
|
|
Overall Study
NOT COMPLETED
|
22
|
28
|
Reasons for withdrawal
| Measure |
Repaglinide
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
7
|
6
|
|
Overall Study
Unclassified
|
12
|
20
|
Baseline Characteristics
Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
Baseline characteristics by cohort
| Measure |
Repaglinide
n=217 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=218 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
Total
n=435 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
217 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
217 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
217 participants
n=5 Participants
|
218 participants
n=7 Participants
|
435 participants
n=5 Participants
|
|
Height
|
163.2 cm
STANDARD_DEVIATION 8.9 • n=5 Participants
|
163.9 cm
STANDARD_DEVIATION 8.4 • n=7 Participants
|
163.5 cm
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Weight
|
68.7 kg
STANDARD_DEVIATION 11.6 • n=5 Participants
|
68.4 kg
STANDARD_DEVIATION 11.2 • n=7 Participants
|
68.6 kg
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Body Mass Index (BMI)
|
25.69 kg/m^2
STANDARD_DEVIATION 3.00 • n=5 Participants
|
25.37 kg/m^2
STANDARD_DEVIATION 3.01 • n=7 Participants
|
25.53 kg/m^2
STANDARD_DEVIATION 3.00 • n=5 Participants
|
|
Duration of diagnosed diabetes
|
1.02 years
STANDARD_DEVIATION 1.95 • n=5 Participants
|
0.79 years
STANDARD_DEVIATION 1.82 • n=7 Participants
|
0.91 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 16Population: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).
Outcome measures
| Measure |
Repaglinide
n=206 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=202 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-0.857 percentage (%) of total haemoglobin
Standard Error 0.051
|
-0.871 percentage (%) of total haemoglobin
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).
Outcome measures
| Measure |
Repaglinide
n=203 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=200 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
-1.409 mmol/L
Standard Error 0.104
|
-1.667 mmol/L
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).
A standard meal contains 100g carbohydrate
Outcome measures
| Measure |
Repaglinide
n=203 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=199 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal
|
-0.596 mmol/L
Standard Error 0.215
|
-0.699 mmol/L
Standard Error 0.211
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).
Outcome measures
| Measure |
Repaglinide
n=217 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=218 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%
|
62 percentage of participants
|
59 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).
Outcome measures
| Measure |
Repaglinide
n=206 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=202 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in Fasting Serum Free Fatty Acid (FFA) From Baseline
|
-0.012 mmol/L
Standard Error 0.014
|
-0.02 mmol/L
Standard Error 0.014
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).
Outcome measures
| Measure |
Repaglinide
n=204 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=201 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal
|
-0.003 mmol/L
Standard Error 0.007
|
-0.004 mmol/L
Standard Error 0.007
|
SECONDARY outcome
Timeframe: Over the course of three hours at Week 0 and Week 16Population: A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.
Outcome measures
| Measure |
Repaglinide
n=31 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=31 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)
|
5139.55 min*pmol/L
Standard Deviation 8720.80
|
1426.21 min*pmol/L
Standard Deviation 5262.15
|
SECONDARY outcome
Timeframe: Over the course of three hours at Week 0 and Week 16Population: A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.
Outcome measures
| Measure |
Repaglinide
n=31 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=31 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in AUC0-180 of Plasma Glucose Concentration of IVGTT
|
-272.30 min*mmol/L
Standard Deviation 290.79
|
-348.03 min*mmol/L
Standard Deviation 258.86
|
SECONDARY outcome
Timeframe: Weeks 0-16Population: Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s). One participant was randomised into repaglinide group, but was dispensed gliclazide from the very beginning of the study due to the investigator's negligence. This participant continued the gliclazide treatment until the end of the study.
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product.
Outcome measures
| Measure |
Repaglinide
n=216 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=219 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Number of All Treatment Emergent Hypoglycaemic Episodes
|
165 episodes
|
147 episodes
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s)
The number of participants having a change in cholesterol from "normal" to "abnormal". "Abnormal" means a value of blood cholesterol is out of the normal range.
Outcome measures
| Measure |
Repaglinide
n=216 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=219 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Cholesterol
|
18 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Week 0, week 16Population: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation
Outcome measures
| Measure |
Repaglinide
n=196 Participants
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=194 Participants
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Change in Body Weight
|
-0.750 kg
Standard Error 0.218
|
-0.511 kg
Standard Error 0.215
|
Adverse Events
Repaglinide
Gliclazide
Serious adverse events
| Measure |
Repaglinide
n=216 participants at risk
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
|
Gliclazide
n=219 participants at risk
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
|
|---|---|---|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.46%
1/216 • Number of events 1 • The adverse events were collected in a timespan of 16 weeks.
Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s).
|
0.00%
0/219 • The adverse events were collected in a timespan of 16 weeks.
Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.46%
1/216 • Number of events 1 • The adverse events were collected in a timespan of 16 weeks.
Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s).
|
0.00%
0/219 • The adverse events were collected in a timespan of 16 weeks.
Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gall bladder cancer
|
0.46%
1/216 • Number of events 1 • The adverse events were collected in a timespan of 16 weeks.
Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s).
|
0.00%
0/219 • The adverse events were collected in a timespan of 16 weeks.
Safety analysis set contains all randomised participants 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. This includes the right to not release interim results of clinical trials. 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