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

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
gliclazide	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
repaglinide	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

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin (HbA1c)	Week 0, week 16

Secondary Outcome Measures

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