A Phase 3 interventional study of Rimonabant and Placebo (for Rimonabant) in Diabetes Mellitus, Type 2, sponsored by Sanofi. Terminated at 13 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-18.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.
Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.
The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 403 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
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Rimonabant 20 mg once daily on top of metformin
Drug: Rimonabant · Drug: Metformin
Placebo (for Rimonabant) once daily on top of metformin
Drug: Placebo (for Rimonabant) · Drug: Metformin
Tablet, oral administration
Also known as: SR141716, Acomplia
Tablet, oral administration
Metformin continued at stable dose as background therapy
Change from baseline in HbA1c
Time frame: 36 weeks
Change from baseline in fasting plasma glucose
Time frame: 36 weeks
Change from baseline in body weight
Time frame: 36 weeks
Percent change from baseline in HDL-C and Triglycerides
Time frame: 36 weeks
The record gives a start of May 2008, a primary completion of Feb 2009 and a completion of Feb 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rimonabant