Dose ranging study of S 44497 administered orally once daily for four weeks in type 2 diabetic patients. A multicentre, randomised, double-blind, double-dummy, phase II study versus placebo and glimepiride and sitagliptin.

• Conditions: Type 2 Diabetes; MedDRA version: 9.1Level: PTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent

• Registration Number: EUCTR2007-003808-35-GB
• Lead Sponsor: Servier Research and Development Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- Men and women aged between 35 and 65 years,
- BMI between 24 and 38 Kg/m2 inclusive,
- Type 2 diabetic patients diagnosed for more than 3 months.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Type 1 diabetes, or diabetes subtype other than type 2, eg slow type 1 diabetes, LADA, haemochromatosis or chronic pancreatitis,
- History of any major symptomatic hyperglycaemic events,
- Metabolic state at risk of rapidly requiring insulin therapy,
- Concomitant disease or planned major surgery that could significantly affect glycemic control during the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): 24-hour glucose profile.;Main Objective: To evaluate the dose-effect relationship of S 44497 using the 24-hour profile of plasma glucose. ;Secondary Objective: - To evaluate the efficacy of S 44497 based on fasting plasma glucose and HbA1c,<br>- To evaluate the pharmacodynamic and pharmacokinetics profile of S 44497,<br>- To assess the safety profile of S 44497.