Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment

Study Overview
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Brief Summary
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This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.

Official Title
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A 16-week, Multicentre, Randomised, Open-label, Parallel Group Study to Investigate the Efficacy and Safety Profiles of Repaglinide Monotherapy Compared to Gliclazide Monotherapy in Chinese Antidiabetic-naïve Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: repaglinide
* Drug: gliclazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed) Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed) Lipid-lowing agent naïve HbA1c: 6.5-8.5% Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl) Body Mass Index (BMI): 20-35 kg/m^2 Be able and willing to perform self-monitored plasma glucose (SMPG) Be able and willing to eat 3 main meals per day Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits Exclusion Criteria: Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs Previous participation in this study Participation in a study of another investigational drug within 1 month prior to study start

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: repaglinide<br>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 | Drug: repaglinide<br>* Individually adjusted dose for 16 weeks<br>|
| Active Comparator: gliclazide<br>80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily | Drug: gliclazide<br>* Individually adjusted dose for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin (HbA1c) |  | Week 0, week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Plasma Glucose |  | Week 0, week 16 | 
| Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal | A standard meal contains 100g carbohydrate | Week 0, week 16 | 
| Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5% |  | Week 16 | 
| Change in Fasting Serum Free Fatty Acid (FFA) From Baseline |  | Week 0, week 16 | 
| Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal |  | Week 0, week 16 | 
| Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test) |  | Over the course of three hours at Week 0 and Week 16 | 
| Change in AUC0-180 of Plasma Glucose Concentration of IVGTT |  | Over the course of three hours at Week 0 and Week 16 | 
| Number of All Treatment Emergent Hypoglycaemic Episodes | 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. | Weeks 0-16 | 
| Cholesterol | 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. | Week 0, week 16 | 
| Change in Body Weight |  | Week 0, week 16 |