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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00546325

NCT00546325
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Type 2 diabetes
  • Your HbA1c (a blood sugar level test) result is between 7% and 9%
  • Your Body Mass Index (BMI) is between 27 and 40
  • You are currently taking both Metformin and Sulfonylurea (two common diabetes medications)

Who may not be able to join:

  • You have a serious, uncontrolled mental health condition such as severe depression
  • You are currently taking antidepressant medication
  • You have severely reduced kidney function (confirm with trial site)
  • You have severe liver disease or certain abnormal liver test results (confirm with trial site)
  • You are currently being treated for epilepsy
  • You are pregnant or breastfeeding
  • You are a woman who could become pregnant and are not using reliable contraception
  • You have a known allergy or sensitivity to the study drug rimonabant or any of its ingredients
  • You have any health condition that the trial doctor believes could put you at risk
  • You have used insulin for more than one week in the four weeks before screening
  • You regularly use steroid medications taken by mouth or injection
  • You currently take certain other diabetes medications including glitazones, GLP-1 therapies, or DPP-4 inhibitors (confirm with trial site)
  • You have a history of drug or alcohol misuse in the last three years
  • You have a serious heart failure condition (classified as Class III or IV)
  • You have severely high blood pressure
  • You currently take certain weight loss medications including phentermine, amphetamines, orlistat, sibutramine, or certain herbal remedies
  • You take certain medications that affect fat levels in the blood, including some hormone therapies, retinoids, fish oils, or cyclosporin (confirm with trial site)
  • You take certain antifungal, antibiotic, anti-seizure, or other specific medications including ketoconazole, ritonavir, carbamazepine, or St John's Wort (confirm with trial site)
  • You have taken part in another clinical trial in the four weeks before joining this study
  • You are currently taking part in a structured weight loss programme
  • You have chronic hepatitis (long-term liver inflammation)
  • You use or misuse substances of abuse
  • You use marijuana or hashish
  • You have had surgery in the past to help with weight loss, or have such surgery planned during the trial
  • You have a history of bulimia or laxative misuse
  • You are not an English speaker

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Sanofi
Registry
clinicaltrials_gov
Start date
1 October 2007
Est. completion
1 February 2009

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Absolute change in HbA1c between both placebo and rimonabant group.; Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%; Percentage of participants responding to treatment; Rate of asymptomatic, symptomatic, and severe hypoglycaemia; Change in physical examinations, vital signs, laboratory parameters, adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov