Safety and Efficacy of Saxagliptin 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:
NCT01619059
First received: June 12, 2012
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to learn if BMS-477118 (Saxagliptin) 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: Saxagliptin
Drug: Dapagliflozin
Drug: Metformin IR
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, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin

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 (Day 1) 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 tolerance test (2-h MTT) at Week 24 [ Time Frame: Baseline (Day 1) and at Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline (Day 1) and at Week 24 ] [ Designated as safety issue: No ]
  • Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0% at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Saxagliptin+Dapagliflozin+Metformin IR Drug: Saxagliptin
Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
Other Name: Onglyza
Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
Drug: Metformin IR
Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks
Experimental: Arm 2: Placebo+Dapagliflozin+Metformin IR Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
Drug: Metformin IR
Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks
Drug: Placebo matching with Saxagliptin
Tablets, Oral, 0 mg, Once daily, Up to 52 weeks

  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 Glycosylated hemoglobin (HbA1c) ≥ 8.0 and ≤ 11.5%
  • Stable dose of metformin for 8 weeks
  • C-peptide ≥ 1.0 ng/mL
  • Body Mass Index ≤ 45.0 kg/m2

Exclusion Criteria:

  • Estimating 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: NCT01619059

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, Alabama
Terence T. Hart, MD Completed
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Mesa Family Medical Center Recruiting
Mesa, Arizona, United States, 85203
Contact: Richard S Dobrusin, Site 007    480-898-0090      
Desert Clinical Research Recruiting
Mesa, Arizona, United States, 85201
Contact: Gerald Shockey, Site 0006    480-898-1300      
Clinical Research Advantage, Inc./ Stonecreek Medical Associates, PC Recruiting
Phoenix, Arizona, United States, 85028
Contact: Thomas Bauch, Site 0026         
Clinical Research Advantage, Inc Recruiting
Phoenix, Arizona, United States, 85020
Contact: Ernie Riffer, Site 0014    480-898-1300      
United States, California
Torrance Clinical Research Recruiting
Lomita, California, United States, 90717
Contact: Marina Raikhel, Site 0003    310-373-8120      
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 0023    760-477-7882      
United States, Colorado
New West Physicians, Pc Recruiting
Golden, Colorado, United States, 80401
Contact: Kenneth Cohen, Site 0050    303-785-5992      
United States, Florida
Clinical Therapeutics Corporation Recruiting
Coral Gables, Florida, United States, 33134
Contact: Baudilio Cusco-Prieto, Site 0013    305-444-9356      
Medical Research Unlimited, Llc Active, not recruiting
Hialeah, Florida, United States, 33012
University Of Florida Endocrinology & Diabetes Recruiting
Jacksonville, Florida, United States, 32207
Contact: Joe Chehade, Site 0029         
Southeast Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact: Kim Barbel-Johnson, Site 0016         
United States, Indiana
Clinical Research Advantage Recruiting
Evansville, Indiana, United States, 7714
Contact: Mohammed A Allaw, Site 0011    812-477-2760      
Clinical Research Advantage, Inc. Recruiting
Evansville, Indiana, United States, 47725
Contact: Anthony Inzerello, Site 0025         
United States, Massachusetts
Clinical Research Of Miami, Inc. Recruiting
Newton, Massachusetts, United States, 02459
Contact: Wilfredo E Bravo, Site 0005    305-264-3025      
Infosphere Clinical Research, Inc. Recruiting
Newton, Massachusetts, United States, 02459
Contact: Dan A Streja, Site 0009    818-222-6868      
United States, Missouri
Mercy Health Research Recruiting
Saint Louis, Missouri, United States, 63141
Contact: James Banks, Site 039    314-251-8890      
United States, Nevada
Clinical Research Advantage, Inc. Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Clifford Molin, Site 0012    702-982-0749      
United States, New Hampshire
Joslin Diabetes Center Affiliate Of Snhmc Recruiting
Nashua, New Hampshire, United States, 03063
Contact: Robert Jeffrey Silver, Site 0020    603-577-5760      
United States, New York
N. Shore Diabetes & Endoc Assoc Recruiting
New Hyde Park, New York, United States, 11042
Contact: Kenneth Hershon, Site 0019    516-327-0850      
United States, North Carolina
Barat Research Group, Inc. Recruiting
Charlotte, North Carolina, United States, 28262
Contact: William J Long Jr., Site 0100    704-316-1800      
United States, Ohio
Physicians Research, Inc. Completed
Zanesville, Ohio, United States, 43701
United States, South Carolina
New England Institutional Review Board (Neirb) Recruiting
Columbia, South Carolina, United States, 29204
Contact: Conigliaro Jones, Site 0102    803-376-8875      
Family Medicine Of Sayebrook Recruiting
Myrtle Beach, South Carolina, United States, 29588
Contact: Edward Mccarthy, Site 0105    843-293-8850      
United States, Tennessee
Holston Medical Group Recruiting
Bristol, Tennessee, United States, 37620
Contact: Rick J Whiles, Site 021    423-990-2497      
Vanderbilt Diabetes Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Shichun Bao, Site 0028    615-936-1149      
United States, Texas
Padre Coast Clinical Research Recruiting
Corpus Christi, Texas, United States, 78404
Contact: Jaime Sandoval, Site 0002    361-881-9300      
Canada, New Brunswick
Local Institution Recruiting
Moncton, New Brunswick, Canada, E1G 1A7
Contact: Site 0035         
Canada, Newfoundland and Labrador
Local Institution Recruiting
St-john, Newfoundland and Labrador, Canada, A1E 2E2
Contact: Site 0037         
Canada, Nova Scotia
Local Institution Recruiting
Halifax, Nova Scotia, Canada, B3K2M5
Contact: Site 0038         
Canada, Ontario
Local Institution Recruiting
Brampton, Ontario, Canada, L6T-0G1
Contact: Site 0017         
Local Institution Recruiting
Sarnia, Ontario, Canada, N7T 4X3
Contact: Site 0036         
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H2R 1V6
Contact: Site 0018         
Canada
Local Institution Recruiting
Quebec, Canada, G3K 2P8
Contact: Site 0097         
Czech Republic
Local Institution Recruiting
Hradec Kralove, Czech Republic, 500 05
Contact: Site 0053         
Local Institution Recruiting
Karlovy Vary, Czech Republic, 360 01
Contact: Site 0045         
Local Institution Recruiting
Praha 5, Czech Republic, 150 98
Contact: Site 0099         
Hungary
Local Institution Recruiting
Balatonfured, Hungary, H-8230
Contact: Site 0081         
Local Institution Recruiting
Budaors, Hungary, 2040
Contact: Site 0082         
Local Institution Recruiting
Budapest, Hungary, 1138
Contact: Site 0093         
Local Institution Recruiting
Zalaegerszeg, Hungary, 8900
Contact: Site 0080         
Mexico
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44650
Contact: Site 0075         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44600
Contact: Site 0078         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44670
Contact: Site 0077         
Local Institution Recruiting
Morelia, Michioacan, Mexico, 58070
Contact: Site 0076         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Site 0073         
Local Institution Recruiting
Del. Benito Juarez, Mexico, 03100
Contact: Site 0072         
Local Institution Recruiting
Veracruz, Mexico, 91910
Contact: Site 0074         
Poland
Local Institution Recruiting
Wegrow, Mazowiekie, Poland, 07-100
Contact: Site 0043         
Local Institution Recruiting
Bialystok, Poland, 15-435
Contact: Site 0058         
Local Institution Recruiting
Katowice, Poland, 40-750
Contact: Site 0061         
Local Institution Recruiting
Katowice, Poland, 40954
Contact: Site 0056         
Local Institution Recruiting
Krakow, Poland, 31-530
Contact: Site 0098         
Local Institution Recruiting
Pszczyna, Poland, 43-200
Contact: Site 0079         
Local Institution Recruiting
Pulawy, Poland, 24-100
Contact: Site 0022         
Local Institution Recruiting
Szczecin, Poland, 70-376
Contact: Site 0051         
Local Institution Recruiting
Warszawa, Poland, 01-868
Contact: Site 0055         
Local Institution Recruiting
Wroclaw, Poland, 50-349
Contact: Site 0052         
Romania
Local Institution Recruiting
Brasov, Romania, 500365
Contact: Site 0041         
Local Institution Recruiting
Bucharest, Romania, 77108
Contact: Site 0047         
Local Institution Recruiting
Bucharest, Romania, 070208
Contact: Site 0040         
Local Institution Recruiting
Bucuresti, Romania, 020045
Contact: Site 0046         
Local Institution Recruiting
Constanta, Romania, 900591
Contact: Site 0059         
Local Institution Recruiting
Craiova, Romania, 200349
Contact: Site 0048         
Local Institution Recruiting
Galati, Romania, 800098
Contact: Site 0042         
Local Institution Recruiting
Ploiesti, Romania, 100097
Contact: Site 0054         
Russian Federation
Local Institution Recruiting
Kursk, Russian Federation, 305035
Contact: Site 0067         
Local Institution Recruiting
Moscow, Russian Federation, 119034
Contact: Site 0096         
Local Institution Recruiting
Saint-petersburg, Russian Federation, 194044
Contact: Site 0064         
Local Institution Recruiting
St. Petersburg, Russian Federation, 197341
Contact: Site 0068         
Local Institution Recruiting
St. Petersburg, Russian Federation, 195257
Contact: Site 0066         
Local Institution Recruiting
St. Petersburg, Russian Federation, 194044
Contact: Site 0070         
Local Institution Recruiting
St. Petersburg, Russian Federation, 197136
Contact: Site 0092         
Local Institution Recruiting
St.petersburg, Russian Federation, 179089
Contact: Site 0069         
Local Institution Recruiting
St.petersburg, Russian Federation, 195112
Contact: Site 0065         
Local Institution Recruiting
Yaroslaval, Russian Federation, 150062
Contact: Site 0062         
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: NCT01619059     History of Changes
Other Study ID Numbers: CV181-168, 2011-006323-37
Study First Received: June 12, 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 22, 2014