A Phase 3 interventional study of Rimonabant and Glimepiride in Diabetes Mellitus, Type 2, sponsored by Sanofi. Terminated at 15 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-16.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
The total duration per patient will be approximately 65 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 508 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.
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Rimonabant 20 mg once daily on top of metformin
Drug: Rimonabant · Drug: Metformin
Glimepiride from 1 mg up to 6 mg once daily on top of metformin
Drug: Glimepiride · Drug: Metformin
Tablet, oral administration
Also known as: SR141716, Acomplia
Tablet, oral administration
Also known as: HOE490, Amaryl
Metformin continued at stable dose as background therapy
Change from baseline in glycemic measure HbA1c
Time frame: 52 weeks (1 year)
Absolute change from baseline in body weight
Time frame: 52 weeks
Relative change from baseline in HDL-C
Time frame: 52 weeks
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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Sanofi