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

This study is currently recruiting participants.
Verified November 2012 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01646320
First received: July 18, 2012
Last updated: March 28, 2013
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Dapagliflozin
Drug: Placebo matching with Dapagliflozin
Drug: Saxagliptin
Drug: Metformin immediate release (IR)
 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, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 280
Study Start Date: January 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR Drug: Dapagliflozin
Tablets, Oral, 10 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: Arm 2: Placebo + Saxagliptin + Metformin IR 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

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646320

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 56 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01646320     History of Changes
Other Study ID Numbers: MB102-129, 2011-006324-20
Study First Received: July 18, 2012
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks

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 May 16, 2013