Type 2 Diabetes patients insufficiently controlled with metformin monotherapy MedDRA version: 10.1 Level: LLT Classification code 10067585 Term:
Conditions
Sponsors
sanofi-aventis recherche & developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented history of type 2 diabetes as defined by 2006 WHO criteria (fasting venous plasma glucose concentration =7.0 mmol/L (126 mg/dl) or 2-h post-glucose load venous plasma glucose =11.1 mmol/L (200 mg/dl) 2. HbA1c between 7% to 10% (inclusive) at Screening Visit 3. Treatment with metformin with a fixed and stable dose of 1500 mg/day or more, and no other anti-diabetic agent for at least the past 3 months prior to 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: • Exclusion criteria related to study methodology: 1. Refusal or inability to give written informed consents to participate in the study 2. Age 5 kg within 3 months prior to Screening Visit 7. C-peptide <1.0 ng/mL at Screening Visit 8. Administration of other investigational drugs within 30 days or 5 half lives, whichever is longer, prior to Screening Visit 9. Participation in a previous rimonabant study 10. Prior exposure to CB1 antagonists including rimonabant 11. Presence of any severe medical or psychological condition that, in the opinion of the Investigator, would compromise the patient’s safe participation including uncontrolled serious psychiatric illness such as major depression, suicidal ideation and medical history of suicide attempt. 12. Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patient’s successful participation for the duration of the study 13. Presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the Investigator (patients on thyroid replacement therapy will be included if the dosage of thyroxine is stable for at least three months prior to Screening Visit) 14. Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer 15. Positive lab test for Hepatitis B surface antigen and/or Hepatitis C antibody at Screening Visit 16. Inability to follow verbal and written instructions • Exclusion criteria related to metformin: 17. Renal disease or renal dysfunction (eg, as suggested by serum creatinine levels =1.5 mg/dL or 132.6 umoles/L [males], =1.4 mg/dL or 123.76 umoles/L [females] or abnormal creatinine clearance) at Screening Visit 18. Presence of congestive heart failure requiring pharmacologic treatment 19. Known hypersensitivity to metformin hydrochloride 20. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. • Exclusion criteria related to rimonabant: 21. Known hypersensitivity/intolerance to rimonabant or any of the excipients of rimonabant tablets such as lactose (such as history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption) 22. Pregnant or breast-feeding women, 23. Women of childbearing potential not protected by effective method of birth control and/or who are unwilling or unable to be tested for pregnancy 24. History of severe hepatic impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the superiority of rimonabant 20 mg versus placebo when added daily to metformin 1500 mg/day (or more) on glycemic control (HbA1c) after 36 weeks treatment in patients with type 2 diabetes mellitus.;Primary end point(s): Change in HbA1c at Week 36 from baseline;Secondary Objective: To evaluate the effect of rimonabant 20 mg added to metformin over a period of 36 weeks on: • Additional markers of glycemic control (eg, fasting plasma glucose, HOMA-IR, insulin) • Lipid profile (HDL-C, Triglycerides, LDL-C, total cholesterol, total cholesterol/HDL-C) • Body weight • Abdominal obesity (as measured by waist circumference) To evaluate the safety of rimonabant 20 mg added to metformin during the entire study period (47 weeks) including assessment of nerve conduction with nerve conduction studies at substudy sites, mood state/alertness (ie, visual analogue scale) and cognition (ie, digit symbol substitution test) at selected sites over the study treatment period. | — |
Countries
Lithuania
Outcome results
None listed