Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01646320
First received: July 18, 2012
Last updated: August 11, 2014
Last verified: September 2013

July 18, 2012
August 11, 2014
September 2012
August 2014   (final data collection date for primary outcome measure)
  • Mean change from baseline in Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline (Day 1) ] [ Designated as safety issue: No ]
  • Mean change from baseline in Glycosylated hemoglobin (HbA1c) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01646320 on ClinicalTrials.gov Archive Site
  • Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in 2-hour post-prandial glucose during a liquid meal tolerance test (2-h MTT) [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in total body weight [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
  • Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
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

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.

Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Dapagliflozin
    Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
  • Drug: Placebo matching with Dapagliflozin
    Tablets, Oral, 0 mg, Once daily, Up to 52 weeks
  • Drug: Saxagliptin
    Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
    Other Name: Onglyza
  • Drug: Metformin immediate release (IR)
    Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks
  • Experimental: Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Saxagliptin
    • Drug: Metformin immediate release (IR)
  • Experimental: Arm 2: Placebo + Saxagliptin + Metformin IR
    Interventions:
    • Drug: Placebo matching with Dapagliflozin
    • Drug: Saxagliptin
    • Drug: Metformin immediate release (IR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
280
February 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   United Kingdom
 
NCT01646320
MB102-129, 2011-006324-20
No
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP