A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
Overview[ - collapse ][ - ]
| Purpose | The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied. |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Dapagliflozin Drug: Dapagliflozin Drug: Metformin Drug: Dapagliflozin Placebo |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01095653 |
| First Received | March 26, 2010 |
| Last Updated | June 25, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 26, 2010 |
|---|---|
| Last Updated Date | June 25, 2013 |
| Start Date | June 2010 |
| Estimated Primary Completion Date | March 2012 |
| 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 With Diet and Exercise |
|---|---|
| Official Title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise |
| Brief Summary | The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. 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, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks Other Names: Glucophage®Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 393 |
| Estimated Completion Date | March 2012 |
| Estimated Primary Completion Date | March 2012 |
| Eligibility Criteria | Inclusion Criteria: - Males and females, 18 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, Taiwan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01095653 |
|---|---|
| Other Study ID Numbers | MB102-054 |
| 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, 100044 |
| Local Institution | Beijing, Beijing, China, 100029 |
| Local Institution | Beijing, Beijing, China, 100730 |
| Local Institution | Beijing, Beijing, China, 100853 |
| Local Institution | Chongqing, Chongqing, China, 40016 |
| Local Institution | Guanzhou, Guangdong, China, 510120 |
| Local Institution | Wuhan, Hubei, China, 430022 |
| Local Institution | Changsha, Hunan, China, 410000 |
| Local Institution | Changsha, Hunan, China, 410008 |
| Local Institution | Nanjing, Jiangsu, China, 210012 |
| Local Institution | Nanjing, Jiangsu, China, 210008 |
| 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, 610072 |
| Local Institution | Tianjin, Tianjin, China, 300211 |
| Local Institution | Hangzhou, Zhejiang, China, 310009 |
| Local Institution | Hangzhou, Zhejiang, China, 310003 |
| Local Institution | Beijing, China, 100034 |
| Local Institution | Wuhan, China, 430030 |
| Local Institution | Xian, China, 710032 |
| Local Institution | Bangalore, Karnataka, India, 560043 |
| Local Institution | Indore, Madhya Pradesh, India, 452010 |
| Local Institution | Bangalore, India, 560092 |
| Local Institution | Jaipur, India, 302023 |
| Local Institution | Seoul, Nowon-GU, Korea, Republic of, 139-711 |
| Local Institution | Busanjin-gu, Korea, Republic of, 633-165 |
| Local Institution | Guri-si, Korea, Republic of, 471-701 |
| Local Institution | Seoul, Korea, Republic of, 137040 |
| Local Institution | Seoul, Korea, Republic of, 120-752 |
| Local Institution | Taichung, Taiwan, 43303 |
| Local Institution | Taichung, Taiwan, 402 |
| Local Institution | Taipei, Taiwan, 235 |
| Local Institution | Taipei, Taiwan, 110 |
| Local Institution | Yung Kang city, Taiwan, 71044 |