Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes | Completed
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
Health Conditions
  • Type 2 Diabetes
Completed
Recruitment Status
NCT01646320
Primary Trial ID Number
Summary
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Primary Outcome Measures
  • Mean change from baseline in Glycosylated hemoglobin (HbA1c); Baseline (Day 1); Mean change from baseline in Glycosylated hemoglobin (HbA1c); Week 24
Secondary Outcome Measures
  • Mean change from baseline in fasting plasma glucose (FPG); Baseline (Day 1) and Week 24; Mean change from baseline in 2-hour post-prandial glucose during a liquid meal tolerance test (2-h MTT); Baseline (Day 1) and Week 24; Mean change from baseline in total body weight; Baseline (Day 1) and Week 24; Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0%; Week 24
Research Question
  • The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; Czech Republic; Mexico; Poland; Puerto Rico; Romania; Russian Federation; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Males and females, ≥ 18 years old, with type 2 diabetes with inadequate glycemic
  • control HbA1c ≥ 7.5% - ≤ 11.5%
  • - Stable dose of Metformin for at least 8 weeks
  • - C-peptide ≥ 1.0 ng/mL
  • - Body Mass Index ≤ 45.0 kg/m2
  • Exclusion Criteria:
  • - Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2 or serum creatinine
  • (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • - Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0 times
  • the upper limit of normal (ULN)
  • - Serum total bilirubin > 2.5 x ULN
  • - Systolic blood pressure (SBP) ≥ 160 mmHg and/or Diastolic blood pressure (DBP) ≥
  • 100mmHg
  • - Cardiovascular disease within 3 months of the screening visit
  • - Currently unstable or serious cardiovascular, renal, hepatic, hematological,
  • oncological, endocrine, psychiatric, or rheumatic diseases
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Males and females, ≥ 18 years old, with type 2 diabetes with inadequate glycemic
  • control HbA1c ≥ 7.5% - ≤ 11.5%
  • - Stable dose of Metformin for at least 8 weeks
  • - C-peptide ≥ 1.0 ng/mL
  • - Body Mass Index ≤ 45.0 kg/m2
  • Exclusion Criteria:
  • - Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2 or serum creatinine
  • (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • - Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0 times
  • the upper limit of normal (ULN)
  • - Serum total bilirubin > 2.5 x ULN
  • - Systolic blood pressure (SBP) ≥ 160 mmHg and/or Diastolic blood pressure (DBP) ≥
  • 100mmHg
  • - Cardiovascular disease within 3 months of the screening visit
  • - Currently unstable or serious cardiovascular, renal, hepatic, hematological,
  • oncological, endocrine, psychiatric, or rheumatic diseases
Interventions
Drug; Dapagliflozin; Tablets, Oral, 10 mg, Once daily, Up to 52 weeks; [Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR]; Drug; Placebo matching with Dapagliflozin; Tablets, Oral, 0 mg, Once daily, Up to 52 weeks; [Arm 2: Placebo + Saxagliptin + Metformin IR]; Drug; Saxagliptin; Tablets, Oral, 5 mg, Once daily, Up to 52 weeks; [Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR, Arm 2: Placebo + Saxagliptin + Metformin IR]; Drug; Metformin immediate release (IR); Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks; [Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR, Arm 2: Placebo + Saxagliptin + Metformin IR]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin
Secondary Trial Identifying Number
2011-006324-20
Website
http://ctr.bms.com/ctd/start.do; http://www.bms.com/studyconnect/Pages/home.aspx; http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx; http://www.fda.gov/MEDWATCH/safety.htm
Study Funded By
Bristol-Myers Squibb
Funder Type
Sorry, this information is not available
Study Sponsored By
Bristol-Myers Squibb
Study Also Sponsored By
AstraZeneca
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

18 Jul 2012

Last Updated

17 Jul 2015

Date Record Refreshed on UKCTG

31 Jul 2015