WHO ICTRP trial
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2…
CTRI/2010/091/000430 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2010/091/000430 |
|---|---|
| Public title | A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone. The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied. |
| Scientific title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone |
| Primary sponsor | The pharmaceutical company sponsoring this study is BristolMyers SquibbAddress |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: null- Type 2 Diabetes |
| Interventions | Intervention1: Dapagliflozin: Tablets, Oral, 5 mg, Once daily, 24 weeks Intervention2: Dapagliflozin: Tablets, Oral, 10 mg, Once daily, 24 weeks Control Intervention1: Dapagliflozin Placebo: Tablets, Oral, 0 mg, Once daily, 24 weeks |
| Registration date | Oct 26, 2010 |
| Target size | 444 |
| Secondary IDs | MB102-055;NCT01095666 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: