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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Saxagliptin
Drug: Metformin XR
Drug: Dapagliflozin
Drug: Placebo matching with Dapagliflozin
Drug: Placebo matching with Saxagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Mean change from baseline in HbA1c at Week 24 [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 536
Study Start Date: July 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Saxagliptin+Metformin XR+Placebo 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: Placebo matching with Dapagliflozin
Tablets, Oral, 0mg, Once daily, 24 weeks
Active Comparator: Arm 2: Dapagliflozin+Metformin XR+Placebo 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 Saxagliptin
Tablets, Oral, 0mg, Once daily, 24 weeks
Experimental: Arm 3: Saxagliptin+Dapagliflozin+Metformin XR 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606007

  Show 139 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01606007     History of Changes
Other Study ID Numbers: CV181-169, 2012-000679-18
Study First Received: May 23, 2012
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
Germany: Federal Institute for Drugs and Medical Devices
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Italy: Ethics Committee
Italy: The Italian Medicines Agency
India: Drugs Controller General of India
India: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014