A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
NCT ID: NCT01095653
Last Updated: 2017-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1179 participants
INTERVENTIONAL
2010-06-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Dapagliflozin
Tablets, Oral, 5 mg, Once daily, 24 weeks
Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Group 2
Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 24 weeks
Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Group 3
Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Interventions
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Dapagliflozin
Tablets, Oral, 5 mg, Once daily, 24 weeks
Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 24 weeks
Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca, Bristol-Myers Squibb
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Hefei, Anhui, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
Local Institution
Guanzhou, Guangdong, China
Local Institution
Wuhan, Hubei, China
Local Institution
Changsha, Hunan, China
Local Institution
Changsha, Hunan, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Wuxi, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Shenyang, Liaoning, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Tianjin, Tianjin Municipality, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Beijing, , China
Local Institution
Wuhan, , China
Local Institution
Xi'an, , China
Local Institution
Bangalore, Karnataka, India
Local Institution
Indore, Madhya Pradesh, India
Local Institution
Bangalore, , India
Local Institution
Jaipur, , India
Local Institution
Seoul, Nowon-GU, South Korea
Local Institution
Busanjin-gu, , South Korea
Local Institution
Guri-si, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Taichung, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Yung Kang City, , Taiwan
Countries
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Related Links
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Other Identifiers
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MB102-054
Identifier Type: -
Identifier Source: org_study_id
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