Type 2 Diabetes MedDRA version: 9.1 Level: PT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Product Name: S44497
Product Code: S44497
Pharmaceutical Form: Capsule*
Current Sponsor code: S44497
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmace
Sponsors
Servier Research and Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, - To evaluate the pharmacodynamic and pharmacokinetics profile of S 44497, - To assess the safety profile of S 44497. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed