Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary: To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) \> 27 kg/m² and BMI \< 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU). Secondary: To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life
Interventions
DRUGRimonabant
White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
DRUGPlacebo
Matching placebo tablets. Once daily before breakfast
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
List of Inclusion and
Exclusion criteria
Inclusion Criteria: * History of Type 2 diabetes * HbA1c between 7% to 9% (inclusive) * BMI ≥ 27kg/m² and BMI ≤ 40kg/m² * Currently taking Metformin and Sulfonylurea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in physical examinations, vital signs, laboratory parameters, adverse events | From the beginning to the end of the study |
| Absolute change in HbA1c between both placebo and rimonabant group. | From baseline to week 48 |
| Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0% | From the beginning to the end of the study |
| Percentage of participants responding to treatment | From the beginning to the end of study |
| Rate of asymptomatic, symptomatic, and severe hypoglycaemia | From the beginning to the end of the study |
Secondary
| Measure | Time frame |
|---|---|
| Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate. | From the beginning to the end of the study |
| Change in BMI, waist and hip circumference, waist/hip ratio, weight | From the beginning to the end of the study |
| Changes in Quality of Life | From the beginning to the end of the study |
| Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B) | From administration of drug till end of study |
| Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio | From administration of drug to end of study |
Countries
Australia
Outcome results
None listed