Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01606007
First received: May 23, 2012
Last updated: March 20, 2014
Last verified: March 2014

May 23, 2012
March 20, 2014
July 2012
January 2014   (final data collection date for primary outcome measure)
Mean change from baseline in HbA1c at Week 24 [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01606007 on ClinicalTrials.gov Archive Site
  • Mean change from baseline in 2-hour post-prandial glucose during a liquid meal test (2-h MTT) [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in body weight at Week 24 with the addition of Saxagliptin and Dapagliflozin to Metformin vs. the addition of placebo and Saxagliptin to Metformin [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. 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, 5mg , Once daily, 24 weeks
    Other Name: Onglyza
  • Drug: Metformin XR
    Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
    Other Name: Glucophage XR
  • Drug: Dapagliflozin
    Tablets, Oral, 10mg , Once daily, 24 weeks
    Other Name: BMS-512148
  • Drug: Placebo matching with Dapagliflozin
    Tablets, Oral, 0mg, Once daily, 24 weeks
  • Drug: Placebo matching with Saxagliptin
    Tablets, Oral, 0mg, Once daily, 24 weeks
  • Active Comparator: Arm 1: Saxagliptin+Metformin XR+Placebo
    Interventions:
    • Drug: Saxagliptin
    • Drug: Metformin XR
    • Drug: Placebo matching with Dapagliflozin
  • Active Comparator: Arm 2: Dapagliflozin+Metformin XR+Placebo
    Interventions:
    • Drug: Metformin XR
    • Drug: Dapagliflozin
    • Drug: Placebo matching with Saxagliptin
  • Experimental: Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
    Interventions:
    • Drug: Saxagliptin
    • Drug: Metformin XR
    • Drug: Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
536
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
  • Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
  • Body mass index (BMI) ≤ 45.0kg/m2

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
  • Hepatic disease
  • Cardiovascular disease within 3 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Mexico,   South Africa,   Romania,   Puerto Rico,   Poland,   Korea, Republic of
 
NCT01606007
CV181-169, 2012-000679-18
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2014

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