Type 2 Diabetic Patients Inadequately Controlled with Insulin MedDRA version: 8.0 Level: LLT Classification code 10063624
Conditions
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged = 18 years • Type 2 diabetes as defined by WHO criteria (fasting venous plasma glucose concentration = 7.0 mmol/L or 2-h post-glucose load venous plasma glucose = 11.1 mmol/L) treated with insulin (any type and regimen) for at least three months (insulin dose = 30 U/day for at least 4 weeks) with HbA1c = 7% at screening Visit 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: • Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least three months prior to screening visit) • Presence of type 1 diabetes (C-peptide 1,000 µg equivalent beclomethasone) within 30 days prior to screening visit - change in the treatment of dyslipidemia within two months prior to screening visit or between screening and baseline visits • Pregnancy or breast-feeding • Absence of effective contraceptive methods for females of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of rimonabant on HbA1c in patients with type 2 diabetes treated with insulin.;Primary end point(s): The primary efficacy endpoint is to evaluate HbA1c.; Secondary Objective: To assess the effect of rimonabant in patients with type 2 diabetes treated with insulin -on body weight -on lipid profile -on abdominal obesity To assess the safety and tolerability of rimonabant in patients with type 2 diabetes treated with insulin | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed