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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01606007
First received: May 23, 2012
Last updated: August 10, 2016
Last verified: August 2016

May 23, 2012
August 10, 2016
July 2012
January 2014   (final data collection date for primary outcome measure)
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
Mean Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01606007 on ClinicalTrials.gov Archive Site
  • Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.
  • Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.
  • Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
    Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
  • Adjusted Mean Change From Baseline in Body Weight at Week 24 [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.
  • 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 ]
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
Rosenstock J, Hansen L, Zee P, Li Y, Cook W, Hirshberg B, Iqbal N. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015 Mar;38(3):376-83. doi: 10.2337/dc14-1142.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1282
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Romania,   South Africa
 
NCT01606007
CV181-169, 2012-000679-18
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
August 2016

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