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

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: repaglinide; Drug: gliclazide

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: repaglinide; Individually adjusted dose for 16 weeks
Active Comparator: 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	Drug: gliclazide; Individually adjusted dose for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: November 26, 2009
• First Submitted That Met QC Criteria: November 26, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Gliclazide; Repaglinide
• Other Study ID Numbers: AGEE-3783; U1111-1111-9453 (Other Identifier: WHO)