A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Dapagliflozin Drug: Dapagliflozin Drug: Metformin Drug: Dapagliflozin Placebo Drug: Pioglitazone |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01095666 |
| First Received | March 26, 2010 |
| Last Updated | June 17, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 26, 2010 |
|---|---|
| Last Updated Date | June 17, 2013 |
| Start Date | June 2010 |
| Estimated Primary Completion Date | March 2013 |
| Current Primary Outcome Measures | Change from baseline in HbA1c for each dose of dapagliflozin vs placebo [Time Frame: At Week 24] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone |
|---|---|
| Official 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 |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Dapagliflozin Tablets, Oral, 5 mg, Once daily, 24 weeks Other Names: BMS-512148Drug: Dapagliflozin Tablets, Oral, 10 mg, Once daily, 24 weeks Other Names: BMS-512148Drug: Metformin Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks Other Names: Glucophage®Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks Drug: Pioglitazone Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 445 |
| Estimated Completion Date | March 2013 |
| Estimated Primary Completion Date | March 2013 |
| Eligibility Criteria | Inclusion Criteria: - Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control - Drug naive or treated with anti-diabetic medication for < 24 weeks - C-peptide ≥ 1.0 ng/mL - Body Mass Index ≤ 45.0 kg/m² Exclusion Criteria: - AST and/or ALT > 3 times ULN - Serum total bilirubin > 2 mg/dL - Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women - Creatine kinase ≥ 3 times ULN - Symptoms of severely uncontrolled diabetes - Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China, India, Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01095666 |
|---|---|
| Other Study ID Numbers | MB102-055 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | AstraZeneca |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | June 2013 |
Locations[ + expand ][ + ]
| Local Institution | Hefei, Anhui, China, 230022 |
|---|---|
| Local Institution | Beijing, Beijing, China, 100700 |
| Local Institution | Beijing, Beijing, China, 100029 |
| Local Institution | Beijing, Beijing, China, 100001 |
| Local Institution | Beijing, Beijing, China, 100044 |
| Local Institution | Beijing, Beijing, China, 100730 |
| Local Institution | Chongqing, Chongqing, China, 400016 |
| Local Institution | Guangzhou, Guangdong, China, 510120 |
| Local Institution | Haerbin, Heilongjiang, China, 150001 |
| Local Institution | Changsha, Hunan, China, 410008 |
| Local Institution | Changsha, Hunan, China, 410000 |
| Local Institution | Nanjing, Jiangsu, China, 210008 |
| Local Institution | Nanjing, Jiangsu, China, 210006 |
| Local Institution | Wuxi, Jiangsu, China, 214023 |
| Local Institution | Changchun, Jilin, China, 130041 |
| Local Institution | Shenyang, Liaoning, China, 110003 |
| Local Institution | Shanghai, Shanghai, China, 200040 |
| Local Institution | Shanghai, Shanghai, China, 200065 |
| Local Institution | Shanghai, Shanghai, China, 200003 |
| Local Institution | Chengdu, Sichuan, China, 610070 |
| Local Institution | Chongqing, Sichuan, China, 400010 |
| Local Institution | Tianjin, Tianjin, China, 300211 |
| Local Institution | Hangzhou, Zhejiang, China, 310009 |
| Local Institution | Xi'An, China, 710032 |
| Local Institution | Bangalore, Karnataka, India, 560 043 |
| Local Institution | Indore, Madhya Pradesh, India, 452010 |
| Local Institution | Bangalore, India, 560092 |
| Local Institution | Jaipur, India, 302023 |
| Local Institution | Vellore, Tamilnadu, India, 632004 |
| Local Institution | Seoul, Nowon-Gu, Korea, Republic of, 139-711 |
| Local Institution | Busan, Korea, Republic of, 614-735 |
| Local Institution | Seoul, Korea, Republic of, 120-752 |
| Local Institution | Seoul, Korea, Republic of, 137-040 |