Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
477 participants
INTERVENTIONAL
2014-03-31
2016-01-28
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
Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Dapagliflozin
Tablet
Group 2: Dapagliflozin Placebo
Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
Dapagliflozin Placebo
Tablet
Interventions
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Dapagliflozin
Tablet
Dapagliflozin Placebo
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment
HbA1c ≥ 7.5 and ≤ 10.5% at Day -14
Exclusion Criteria
* History of diabetic ketoacidosis of hyperosmolar nonketotic coma
* Clinically diagnosed Type 1 diabetes mellitus
* Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
* Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
* History of unstable or rapidly progressing renal disease
* History of severe hepatobiliary disease
* Mallingancy within 5 years of the screening/enrollment visit
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Local Institution
Singapore, , Singapore
Local Institution
Singapore, , Singapore
Local Institution
Busan, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Daejeon, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Haerbin, Heilongjiang, China
Local Institution
Changsha, Hunan, China
Local Institution
Changsha, Hunan, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Suzhou, Jiangsu, China
Local Institution
Wuxi, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Xi’an, Shanxi, China
Local Institution
Xi’an, Shanxi, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Chongqing, Sichuan, China
Local Institution
Beijing, , China
Local Institution
Tianjin, , China
Countries
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References
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Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Other Identifiers
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MB102-137
Identifier Type: -
Identifier Source: org_study_id
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