Assessment of blood glucose profile in type 2 diabetic patients after a one-week treatment with gliclazide 60 mg MR using both the glycaemic Holter method and multiple blood glucose samples.A double-blind, randomized, parallel group, placebo-controlled, exploratory study.

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2008-002647-16-GB
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

. Type 2 diabetic patients
. Between 35 and 70 years of age inclusive,
. Diagnosed with diabetes for at least 3 months,
. Body Mass Index (BMI) between 24 and 38 kg/m2 inclusive,
. Currently treated with metformin alone.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Pregnancy, breast-feeding or female of childbearing potential not using appropriate contraception,
· Special diet or substantial changes in eating habits in the last 3 months,
. Type 1 diabetes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: · To study the glycaemic Holter and the multiple venous blood glucose samples methods to assess the blood glucose profile over 24 hours in type 2 diabetic patients after 7-day repeated oral dose administration with gliclazide;Secondary Objective: · To assess the short-term treatment effect of gliclazide versus placebo, on top of metformin, based on glucose profile over 24 hours using the glycaemic Holter and the multiple venous blood glucose samples methods<br>· To optimise the duration of the glycaemic Holter recording <br>· To provide information on the plasma pharmacokinetic profile of gliclazide in type 2 diabetic patients<br>;Primary end point(s): Blood glucose profile using glycaemic Holter and method of multiple venous blood glucose samples