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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022762
• Other study ID #: AGEE-3783
• Secondary ID: U1111-1111-9453
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2009
• Last updated: June 25, 2014
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• repaglinide
Individually adjusted dose for 16 weeks
• gliclazide
Individually adjusted dose for 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c)		Week 0, week 16	No
Secondary	Change in Fasting Plasma Glucose		Week 0, week 16	No
Secondary	Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal	A standard meal contains 100g carbohydrate	Week 0, week 16	No
Secondary	Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%		Week 16	No
Secondary	Change in Fasting Serum Free Fatty Acid (FFA) From Baseline		Week 0, week 16	No
Secondary	Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal		Week 0, week 16	No
Secondary	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	No
Secondary	Change in AUC0-180 of Plasma Glucose Concentration of IVGTT		Over the course of three hours at Week 0 and Week 16	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Body Weight		Week 0, week 16	No

External Links

•   Clinical Trials at Novo Nordisk