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

Novo Nordisk A/S440 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

440

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

repaglinideDRUG

Individually adjusted dose for 16 weeks

gliclazideDRUG

Individually adjusted dose for 16 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, week 16

Secondary Outcomes

Change in Fasting Plasma Glucose

Time frame: Week 0, week 16

Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal

A standard meal contains 100g carbohydrate

Time frame: Week 0, week 16

Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%

Time frame: Week 16

Change in Fasting Serum Free Fatty Acid (FFA) From Baseline

Time frame: Week 0, week 16

Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal

Time frame: Week 0, week 16

Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)

Time frame: Over the course of three hours at Week 0 and Week 16

Change in AUC0-180 of Plasma Glucose Concentration of IVGTT

Time frame: 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.

Time frame: Weeks 0-16

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.