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 DiabetesMedDRA version: 9.1Level: PTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent
- Registration Number
- EUCTR2007-003808-35-DE
- Lead Sponsor
- Institut de Recherches Internationales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
- 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
- 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 Main Objective: To evaluate the dose-effect relationship of S44497 using the 24-hour profile of plasma glucose. ;Secondary Objective: - To evaluate the efficacy of S44497 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 S44497.;Primary end point(s): 24-hour glucose profile.
- Secondary Outcome Measures
Name Time Method