A Phase 3 interventional study of Rimonabant and Placebo (for Rimonabant) in Obesity and Diabetes Mellitus Type 2, sponsored by Sanofi. Terminated at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-06-06.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).
The secondary objectives are:
The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 458 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Rimonabant 20 mg once daily
Drug: Rimonabant · Drug: Anti-diabetic monotherapy
Placebo (for Rimonabant) once daily
Drug: Placebo (for Rimonabant) · Drug: Anti-diabetic monotherapy
Tablet, oral administration
Also known as: SR141716, Acomplia
Tablet, oral administration
Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period
Absolute change from baseline in HbA1C
Time frame: Baseline to week 52
Relative change from baseline in in body weight
Time frame: Baseline to week 52
Absolute change from baseline in Fasting Plasma Glucose
Time frame: Baseline to week 52
Absolute change from baseline in waist circumference
Time frame: Baseline to week 52
Relative change from baseline in Triglycerides and HDL-cholesterol
Time frame: Baseline to week 52
Safety: overview of adverse events
Time frame: Baseline to Week 56
This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi