Safety and Efficacy of Saxagliptin 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:
NCT01619059
First received: June 12, 2012
Last updated: August 8, 2014
Last verified: August 2014
  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 ]

Enrollment: 317
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
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
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: NCT01619059

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
Terence T. Hart, Md
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Clinical Research Advantage Inc/Desert Clinical Research Llc
Mesa, Arizona, United States, 85213
Mesa Family Medical Center
Mesa, Arizona, United States, 85203
Clinical Research Advantage, Inc
Phoenix, Arizona, United States, 85020
Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc
Phoenix, Arizona, United States, 85028
United States, California
Beach Physicians Clinical Research Corp.
Huntington Beach, California, United States, 92647
Torrance Clinical Research
Lomita, California, United States, 90717
Randall G. Shue, Do, Inc.
Los Angeles, California, United States, 90023
National Research Institute
Los Angeles, California, United States, 90057
Cassidy Medical Group/Clinical Research Advantage
Vista, California, United States, 92083
Infosphere Clinical Research, Inc.
West Hills, California, United States, 91307
United States, Colorado
New West Physicians, Pc
Golden, Colorado, United States, 80401
United States, Florida
Southeast Clinical Research, Llc
Chiefland, Florida, United States, 32626
Clinical Therapeutics Corporation
Coral Gables, Florida, United States, 33134
Medical Research Unlimited, Llc
Hialeah, Florida, United States, 33012
Care Partners Clinical Research, Llc
Jacksonville, Florida, United States, 32277
University Of Florida Endocrinology & Diabetes
Jacksonville, Florida, United States, 32207
Clinical Research Of Miami, Inc.
Miami, Florida, United States, 33126
United States, Indiana
Clinical Research Advantage
Evansville, Indiana, United States, 7714
Clinical Research Advantage, Inc.
Evansville, Indiana, United States, 47725
United States, Missouri
Mercy Health Research
Saint Louis, Missouri, United States, 63141
United States, Nevada
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Joslin Diabetes Center Affiliate Of Snhmc
Nashua, New Hampshire, United States, 03063
United States, New York
N. Shore Diabetes & Endoc Assoc
New Hyde Park, New York, United States, 11042
Digiovanna Institute For Medical Education & Research
North Massapequa, New York, United States, 11758
United States, North Carolina
Barat Research Group, Inc.
Charlotte, North Carolina, United States, 28262
United States, Ohio
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States, 45219
Physicians Research, Inc.
Zanesville, Ohio, United States, 43701
United States, South Carolina
Tlm Medical Services
Columbia, South Carolina, United States, 29204
Family Medicine Of Sayebrook
Myrtle Beach, South Carolina, United States, 29588
United States, Tennessee
Holston Medical Group
Bristol, Tennessee, United States, 37620
Vanderbilt Diabetes Center
Nashville, Tennessee, United States, 37232
United States, Texas
Padre Coast Clinical Research
Corpus Christi, Texas, United States, 78404
Canada, New Brunswick
Local Institution
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Newfoundland and Labrador
Local Institution
St-john, Newfoundland and Labrador, Canada, A1E 2E2
Canada, Nova Scotia
Local Institution
Halifax, Nova Scotia, Canada, B3K2M5
Canada, Ontario
Local Institution
Brampton, Ontario, Canada, L6T-0G1
Local Institution
Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2R 1V6
Canada
Local Institution
Quebec, Canada, G3K 2P8
Czech Republic
Local Institution
Hradec Kralove, Czech Republic, 500 05
Local Institution
Karlovy Vary, Czech Republic, 360 01
Local Institution
Praha 5, Czech Republic, 150 98
Hungary
Local Institution
Balatonfured, Hungary, H-8230
Local Institution
Budaors, Hungary, 2040
Local Institution
Budapest, Hungary, 1138
Local Institution
Zalaegerszeg, Hungary, 8900
Mexico
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Guadalajara, Jalisco, Mexico, 44650
Local Institution
Guadalajara, Jalisco, Mexico, 44600
Local Institution
Morelia, Michioacan, Mexico, 58070
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Del. Benito Juarez, Mexico, 03100
Local Institution
Veracruz, Mexico, 91910
Poland
Local Institution
Bialystok, Poland, 15-435
Local Institution
Katowice, Poland, 40-750
Local Institution
Katowice, Poland, 40954
Local Institution
Krakow, Poland, 31-530
Local Institution
Pszczyna, Poland, 43-200
Local Institution
Pulawy, Poland, 24-100
Local Institution
Szczecin, Poland, 70-376
Local Institution
Warszawa, Poland, 01-868
Local Institution
Wegrow, Poland, 07-100
Local Institution
Wroclaw, Poland, 50-349
Puerto Rico
Research & Cardiovascular Corp
Ponce, Puerto Rico, 00717
Romania
Local Institution
Brasov, Romania, 500365
Local Institution
Bucharest, Romania, 77108
Local Institution
Bucharest, Romania, 070208
Local Institution
Bucuresti, Romania, 020045
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, 194044
Local Institution
St. Petersburg, Russian Federation, 195257
Local Institution
St. Petersburg, Russian Federation, 197136
Local Institution
St. Petersburg, Russian Federation, 197341
Local Institution
St.petersburg, Russian Federation, 195112
Local Institution
St.petersburg, Russian Federation, 197022
Local Institution
Yaroslaval, Russian Federation, 150062
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: August 8, 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014