Patients with Type 2 diabetes not treated by a pharmacological agent. MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Sponsors
Sanofi-Synthelabo Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged = 18 years. • Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months but no longer than 3 years. • Type 2 diabetes not previously treated by a pharmacological agent. • HbA1C = 7% and = 10%. 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
Exclusion criteria: • Weight loss > 5 kg within 3 months prior to screening visit. • Pregnancy or lactation. • Absence of medically approved contraceptive methods for females of childbearing potential. • Marijuana or hashish users. • Presence or history of allergic reaction or intolerance to multiple drugs. • Presence of any other condition (e.g. geographic, social …) actual or anticipated, that the Investigator feels that would restrict or limit the patient’s participation for the duration of the study. • No use of any oral antidiabetic agent is allowed prior to the entry of the study, except for the conditions described in the protocol. • No use of insulin is allowed prior to the entry of the study, except for the conditions described in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first primary objective is to assess the antidiabetic effect of rimonabant (HbA1C) over a period of 6 months when prescribed in treatment-naïve type 2 diabetes patients.;Secondary Objective: • To assess the effect of rimonabant over a period of 6 months on : - other markers of glycemic control (fasting glucose, fasting-insulin and C-peptide) and on insulin resistance/insulin sensitivity and ß-cell function (HOMA indices); - Body weight. - other risk factors (HDL-Cholesterol, TG, blood pressure). • To evaluate the safety and tolerability of rimonabant over a period of 6 months in this treatment naïve population.;Primary end point(s): The primary endpoint is the absolute change in HbA1C from baseline to Month 6. | — |
Countries
Germany, United Kingdom
Outcome results
None listed