Safety and Efficacy of Saxagliptin 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:
NCT01619059
First received: June 12, 2012
Last updated: July 29, 2014
Last verified: July 2014

June 12, 2012
July 29, 2014
June 2012
June 2014   (final data collection date for primary outcome measure)
Mean change from baseline in HbA1c at Week 24 [ Time Frame: Baseline (Day 1) and At Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01619059 on ClinicalTrials.gov Archive Site
  • Mean change from baseline in 2-hour post-prandial glucose during a liquid meal tolerance test (2-h MTT) at Week 24 [ Time Frame: Baseline (Day 1) and at Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline (Day 1) and at Week 24 ] [ Designated as safety issue: No ]
  • Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0% at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Saxagliptin 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 Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin

The purpose of this study is to learn if BMS-477118 (Saxagliptin) 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.

Not Provided
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: Saxagliptin
    Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
    Other Name: Onglyza
  • Drug: Dapagliflozin
    Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
  • Drug: Metformin IR
    Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks
  • Drug: Placebo matching with Saxagliptin
    Tablets, Oral, 0 mg, Once daily, Up to 52 weeks
  • Experimental: Arm 1: Saxagliptin+Dapagliflozin+Metformin IR
    Interventions:
    • Drug: Saxagliptin
    • Drug: Dapagliflozin
    • Drug: Metformin IR
  • Experimental: Arm 2: Placebo+Dapagliflozin+Metformin IR
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Metformin IR
    • Drug: Placebo matching with Saxagliptin
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
317
January 2015
June 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 Glycosylated hemoglobin (HbA1c) ≥ 8.0 and ≤ 11.5%
  • Stable dose of metformin for 8 weeks
  • C-peptide ≥ 1.0 ng/mL
  • Body Mass Index ≤ 45.0 kg/m2

Exclusion Criteria:

  • Estimating 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,   Canada,   Czech Republic,   Hungary,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation
 
NCT01619059
CV181-168, 2011-006323-37
No
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2014

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