Roche Diabetes 035
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Iii Study To Assess The Efficacy, Safety And Tolerability Of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin In Patients With Type 2 Diabetes Mellitus (T2d) Inadequately Controlled With Metformin Monotherapy.
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| Identifier | BC28035 |
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| UID | 195df992-7c35-4532-9d98-e969ba593ccd |
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| Status | Done - Archived |
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| Phase | 3 |
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| Category | Diabetes Type 2 / Adult |
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| Launch Year | 2012 |
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| NCT Number | - |
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| Created | 2012-06-21 18:24 |
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| Last Updated | 2012-06-21 18:24 |
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Description
Key Elements:
• Study purpose: To evaluate the efficacy of Aleglitazar plus Metformin on glycemic control compared with placebo plus Metformin in patients with TD inadequately controlled with Metformin, as assessed by HbA1c after 26 weeks of treatment.
• Study drug: Aleglitazar belongs to the glitazar class of medications (Pioglitazone/Actos, Rosiglitazone/Avandia). Aleglitazar has been studies in 11 clinical trials and has shown to lower triglyerids and LDL-C, as well as a tendency for positive effects on cardiovascular outcomes and slight decrease in SBP and DBP.
• Study Drug Administration: 1 tablet, once-daily, at any time of day, with or without food.
• 8 visits over the course of 32 weeks/8 months.
• HbA1c >7.0 to<9.5
• Stipend: $45
Comment
No comment.
