A randomized, double blind, placebo controlled study evaluating the glycemic effect of rimonabant added to metformin in patients with type 2 diabetes insufficiently controlled with metformin monotherapy - TOCCATA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 360

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 related to study methodology:
1. Refusal or inability to give written informed consents to participate in the study
2. Age <18 years old or below legal age of majority
3. Change in lipid modifying agent including introduction, change in dose or cessation in the 3 months prior to Screening Visit
4. Administration of long acting systemic corticosteroids of any duration or other systemic corticosteroids for more than 10 days in the previous 3 months from Screening Visit
5. Use of any anti-obesity agent or drugs for weight loss (eg, sibutramine, orlistat, herbal preparations, phentermine, amphetamines) in the 3 months prior to Screening visit
6. Weight loss of >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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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