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

This study is currently recruiting participants.
Verified September 2013 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: September 4, 2013
Last verified: September 2013
  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: October 2015
Estimated Primary Completion Date: December 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.

  Hide Study Locations
Locations
United States, Arizona
Clinical Research Advantage Inc/Desert Clinical Research Llc Recruiting
Mesa, Arizona, United States, 85213
Contact: Gerald Shockey, Site 0004    480-898-1300      
Stonecreek Medical Associates, Pc/Clinical Research Advantage Recruiting
Phoenix, Arizona, United States, 85028
Contact: Thomas Bauch, Site 0006    602-386-3480      
Elite Clinical Studies, Llc Recruiting
Phoenix, Arizona, United States, 85018
Contact: Joseph Lillo, Site 0094    602-788-3437      
United States, Arkansas
Arkansas Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kevin D Roberts, Site 0099         
United States, California
National Research Inst Active, not recruiting
Los Angeles, California, United States, 90057
Cassidy Medical Group/Clinical Research Advantage Recruiting
Vista, California, United States, 92083
Contact: Terry Haas, Site 0002    760-477-7882      
United States, Florida
Palm Springs Research Institute Recruiting
Hialeah, Florida, United States, 33012
Contact: Farid Marquez, Site 0021    305-827-3335      
International Research Associates, Llc Recruiting
Miami, Florida, United States, 33183
Contact: Cristian Breton, Site 0034    305-670-8830      
Compass Research East, Llc Recruiting
Oviedo, Florida, United States, 32765
Contact: Bradley Block, Site 0098         
United States, Indiana
Clinical Research Advantage Recruiting
Evansville, Indiana, United States, 47714
Contact: Mohammed A Allaw, Site 005    812-477-2760      
United States, North Carolina
Metrolina Internal Medicine Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Latimer Taylor, Site 0012    704-374-0030      
United States, Ohio
Sterling Research Grp, Ltd. Recruiting
Cincinnati, Ohio, United States, 45246
Contact: Curtis Taylor, Site 0038    513-381-4100      
United States, Texas
Endocrine Associates Recruiting
Houston, Texas, United States, 77004
Contact: Gerardo Bueso, Site 0011    713-520-8385      
Sam Clinical Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Sam Miller, Site 0033         
United States, Virginia
Tidewater Integrated Medical Research Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Gregory Haase, Site 0092    757-233-9280      
Czech Republic
Local Institution Recruiting
Broumov, Czech Republic, 550 01
Contact: Site 0106         
Local Institution Recruiting
Pardubice, Czech Republic, 530 02
Contact: Site 0047         
Local Institution Completed
Praha 10, Czech Republic, 100 00
Local Institution Recruiting
Praha 4, Czech Republic, 149 00
Contact: Site 0081         
Local Institution Not yet recruiting
Pribram I, Czech Republic, 261 26
Contact: Site 0105         
Mexico
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44670
Contact: Site 0077         
Local Institution Recruiting
Zapopan, Jalisco, Mexico, 45116
Contact: Site 0095         
Local Institution Recruiting
Zapopan, Jalisco, Mexico, 45200
Contact: Site 0074         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Site 0078         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64060
Contact: Site 0075         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Site 0076         
Local Institution Recruiting
Aguascalientes, Mexico, 20127
Contact: Site 0096         
Poland
Local Institution Recruiting
Bialystok, Poland, 15-435
Contact: Site 0080         
Local Institution Not yet recruiting
Krakow, Poland, 30-015
Contact: Site 0108         
Local Institution Recruiting
Ruda Slaska, Poland, 41-709
Contact: Site 0101         
Local Institution Recruiting
Warszawa, Poland, 01-868
Contact: Site 0068         
Local Institution Not yet recruiting
Warszawa, Poland, 00-465
Contact: Site 0110         
Local Institution Completed
Warszawa, Poland, 03-003
Local Institution Recruiting
Zory, Poland, 44-240
Contact: Site 0069         
Romania
Local Institution Recruiting
Bucharest, Romania, 010825
Contact: Site 0073         
Local Institution Recruiting
Bucharest, Romania, 070208
Contact: Site 0052         
Local Institution Recruiting
Constanta, Romania, 900591
Contact: Site 0053         
Local Institution Recruiting
Craiova, Romania, 200349
Contact: Site 0054         
Local Institution Recruiting
Galati, Romania, 800098
Contact: Site 0050         
Local Institution Recruiting
Ploiesti, Romania, 100097
Contact: Site 0051         
Russian Federation
Local Institution Recruiting
Kursk, Russian Federation, 305035
Contact: Site 0063         
Local Institution Recruiting
Moscow, Russian Federation, 119034
Contact: Site 0072         
Local Institution Not yet recruiting
Saint-petersburg, Russian Federation, 191015
Contact: Site 0056         
Local Institution Not yet recruiting
Saint-petersburg, Russian Federation, 194044
Contact: Site 0093         
Local Institution Recruiting
St. Petersburg, Russian Federation, 194044
Contact: Site 0059         
Local Institution Recruiting
St. Petersburg, Russian Federation, 194156
Contact: Site 0057         
Local Institution Recruiting
St. Petersburg, Russian Federation, 195257
Contact: Site 0062         
Local Institution Recruiting
St. Petersburg, Russian Federation, 197136
Contact: Site 0060         
Local Institution Recruiting
St.petersburg, Russian Federation, 195112
Contact: Site 0061         
Local Institution Recruiting
St.petersburg, Russian Federation, 179089
Contact: Site 0058         
Local Institution Recruiting
Yaroslaval, Russian Federation, 150062
Contact: Site 0055         
United Kingdom
Local Institution Recruiting
Newport, Isle of Wight, United Kingdom, PO30 5TG
Contact: Site 0090         
Local Institution Recruiting
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Site 0085         
Local Institution Recruiting
Chippenham, Wiltshire, United Kingdom, SN15 1HP
Contact: Site 0091         
Local Institution Recruiting
Bedfordshire, United Kingdom, SG19 3JR
Contact: Site 0086         
Local Institution Recruiting
London, United Kingdom, W6 7HY
Contact: Site 0088         
Local Institution Recruiting
Portsmouth, United Kingdom, P06 3LY
Contact: Site 0083         
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: September 4, 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 April 16, 2014