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Safety and Efficacy of Dapagliflozin 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:
NCT01646320
First received: July 18, 2012
Last updated: November 20, 2014
Last verified: October 2014
  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:


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: September 2012
Estimated Study Completion Date: February 2015
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Clinical Research Advantage Inc/Desert Clinical Research Llc
Mesa, Arizona, United States, 85213
Clinical Research Advantage, Inc.
Phoenix, Arizona, United States, 85018
Elite Clinical Studies, Llc
Phoenix, Arizona, United States, 85018
United States, Arkansas
Arkansas Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
Torrance Clinical Research Institute Inc.
Lomita, California, United States, 90717
National Research Institute
Los Angeles, California, United States, 90057
Randall G. Shue, Do, Inc.
Los Angeles, California, United States, 90023
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Cassidy Medical Group/Clinical Research Advantage
Vista, California, United States, 92083
United States, Florida
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
Fpa Clinical Research
Kissimmee, Florida, United States, 34741
International Research Associates, Llc
Miami, Florida, United States, 33183
Omega Research Consultants, Llc
Orlando, Florida, United States, 32804
Compass Research East, Llc
Oviedo, Florida, United States, 32765
Palm Harbor Medical Associates
Palm Harbor, Florida, United States, 34684
United States, Illinois
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
United States, Indiana
Clinical Research Advantage
Evansville, Indiana, United States, 47714
United States, Michigan
Associated Internal Medicine Specialists
Battle Creek, Michigan, United States, 49015
United States, Mississippi
Jackson Clinic
Rolling Fork, Mississippi, United States, 39159
United States, New Jersey
Premier Research
Trenton, New Jersey, United States, 08611
United States, North Carolina
Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
United States, Ohio
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States, 45246
United States, Texas
Endocrine Associates
Houston, Texas, United States, 77004
Sam Clinical Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23454
Czech Republic
Local Institution
Broumov, Czech Republic, 550 01
Local Institution
Pardubice, Czech Republic, 530 02
Local Institution
Praha 10, Czech Republic, 100 00
Local Institution
Praha 4, Czech Republic, 149 00
Local Institution
Pribram V, Czech Republic, 261 95
Mexico
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Zapopan, Jalisco, Mexico, 45200
Local Institution
Zapopan, Jalisco, Mexico, 45116
Local Institution
Monterrey, Nuevo Leon, Mexico, 64060
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Aguascalientes, Mexico, 20127
Poland
Local Institution
Bialystok, Poland, 15-435
Local Institution
Krakow, Poland, 30-015
Local Institution
Ruda Slaska, Poland, 41-709
Local Institution
Warszawa, Poland, 00-465
Local Institution
Warszawa, Poland, 03-003
Local Institution
Warszawa, Poland, 01-868
Local Institution
Zory, Poland, 44-240
Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
Romania
Local Institution
Bucharest, Romania, 070208
Local Institution
Bucharest, Romania, 010825
Local Institution
Constanta, Romania, 900591
Local Institution
Craiova, Romania, 200349
Local Institution
Galati, Romania, 800098
Local Institution
Ploiesti, Romania, 100097
Russian Federation
Local Institution
Kursk, Russian Federation, 305035
Local Institution
Moscow, Russian Federation, 119034
Local Institution
Saint-petersburg, Russian Federation, 194044
Local Institution
St. Petersburg, Russian Federation, 195257
Local Institution
St. Petersburg, Russian Federation, 194044
Local Institution
St. Petersburg, Russian Federation, 194156
Local Institution
St. Petersburg, Russian Federation, 197136
Local Institution
St.petersburg, Russian Federation, 195112
Local Institution
St.petersburg, Russian Federation, 197022
Local Institution
Yaroslaval, Russian Federation, 150062
United Kingdom
Local Institution
Portsmouth, Hants, United Kingdom, PO3 6LY
Local Institution
Newport, Isle of Wight, United Kingdom, PO30 5TG
Local Institution
Liverpool, Merseyside, United Kingdom, L7 8XP
Local Institution
Chippenham, Wiltshire, United Kingdom, SN15 1HP
Local Institution
Bedfordshire, United Kingdom, SG19 3JR
Local Institution
London, United Kingdom, W6 7HY
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: NCT01646320     History of Changes
Other Study ID Numbers: MB102-129, 2011-006324-20
Study First Received: July 18, 2012
Last Updated: November 20, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014