Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01606007
First received: May 23, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.


Condition Intervention Phase
Type 2 Diabetes
Drug: Saxagliptin
Drug: Metformin XR
Drug: Dapagliflozin
Drug: Placebo matching with Dapagliflozin
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, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

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 (Week 0) 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 test (2-h MTT) [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in body weight at Week 24 with the addition of Saxagliptin and Dapagliflozin to Metformin vs. the addition of placebo and Saxagliptin to Metformin [ Time Frame: Baseline (Week 0) and at Week 24 ] [ Designated as safety issue: No ]

Enrollment: 536
Study Start Date: July 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Saxagliptin+Metformin XR+Placebo Drug: Saxagliptin
Tablets, Oral, 5mg , Once daily, 24 weeks
Other Name: Onglyza
Drug: Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Other Name: Glucophage XR
Drug: Placebo matching with Dapagliflozin
Tablets, Oral, 0mg, Once daily, 24 weeks
Active Comparator: Arm 2: Dapagliflozin+Metformin XR+Placebo Drug: Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Other Name: Glucophage XR
Drug: Dapagliflozin
Tablets, Oral, 10mg , Once daily, 24 weeks
Other Name: BMS-512148
Drug: Placebo matching with Saxagliptin
Tablets, Oral, 0mg, Once daily, 24 weeks
Experimental: Arm 3: Saxagliptin+Dapagliflozin+Metformin XR Drug: Saxagliptin
Tablets, Oral, 5mg , Once daily, 24 weeks
Other Name: Onglyza
Drug: Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Other Name: Glucophage XR
Drug: Dapagliflozin
Tablets, Oral, 10mg , Once daily, 24 weeks
Other Name: BMS-512148

  Eligibility

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

Inclusion Criteria:

  • Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
  • Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
  • Body mass index (BMI) ≤ 45.0kg/m2

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
  • Hepatic disease
  • Cardiovascular disease within 3 months
  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: NCT01606007

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Locations
United States, Alabama
Central Alabama Research
Birmingham, Alabama, United States, 35209
Central Alabama Research
Homewood, Alabama, United States, 35244
Terence T. Hart, Md
Muscle Shoals, Alabama, United States, 35662
International Institute Of Clinical Research
Ozark, Alabama, United States, 36360
United States, Arizona
Clinical Research Advantage
Mesa, Arizona, United States, 85206
Elite Clinical Studies, Llc
Phoenix, Arizona, United States, 85018
Genova Clinical Research
Tucson, Arizona, United States, 85704
United States, Arkansas
Medical Investigations, Inc.
Little Rock, Arkansas, United States, 72205
Aureus Research, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States, 92708
Torrance Clinical Research
Lomita, California, United States, 90717
National Research Inst
Los Angeles, California, United States, 90057
Providence Clinical Research
North Hollywood, California, United States, 91606
Mehrdad Kevin Ariani Md, Inc.
Northridge, California, United States, 91325
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Lucita M. Cruz,Md.,Inc.
Norwalk, California, United States, 90650
Center For Clinical Trials, Llc.
Paramount, California, United States, 90723
Center For Clinical Trials Of Sacramento, Inc.
Sacramento, California, United States, 95823
Trinitas Research, Inc
San Jose, California, United States, 95116
Orange County Research Center
Tustin, California, United States, 92780
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Clinical Research Advantage
Colorado Springs, Colorado, United States, 80906
Infocus Clinical Research
Denver, Colorado, United States, 80211
Lynn Institute Of Denver
Denver, Colorado, United States, 80246
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Southeast Clinical Research, Llc
Chiefland, Florida, United States, 32626
Clinical Therapeutics Corporation
Coral Gables, Florida, United States, 33134
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Jacksonville, Florida, United States, 32216
Fpa Clinical Research
Kissimmee, Florida, United States, 34741
Clinical Research Of Miami, Inc.
Miami, Florida, United States, 33126
Advanced Pharma Cr, Llc
Miami, Florida, United States, 33136
Newphase Clinical Trials, Inc.
Miami Beach, Florida, United States, 33140
Omega Research Consultants, Llc
Orlando, Florida, United States, 32804
Palm Harbor Medical Associates
Palm Harbor, Florida, United States, 34684
Andres Patron, Do Pa
Pembroke Pines, Florida, United States, 33026
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Endocrine Research Solutions, Inc.
Roswell, Georgia, United States, 30076
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Cedar Crosse Research Center
Chicago, Illinois, United States, 60607-4559
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Vernon Hills, Illinois, United States, 60061
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Council Bluffs, Iowa, United States, 51503
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Horizon Research Group Of Opelousas, Llc
Eunice, Louisiana, United States, 70535
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Associated Internal Medicine Specialists
Battle Creek, Michigan, United States, 49015
Harris And Associates, P.C.
Detroit, Michigan, United States, 48235
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Patterson Medical Clinic
Florissant, Missouri, United States, 63031
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Bellevue Family Practice
Bellevue, Nebraska, United States, 68005
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Elkhorn, Nebraska, United States, 68022
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Fremont, Nebraska, United States, 68025
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Omaha, Nebraska, United States, 68130
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Blackwood, New Jersey, United States, 08012
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Elizabeth, New Jersey, United States, 07205
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Southgate Medical Group
West Seneca, New York, United States, 14224
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Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
Triad Clinical Trials, Llc
Greensboro, North Carolina, United States, 27410
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States, 28557
Pmg Research Of Winston-Salem, Llc
Winston-salem, North Carolina, United States, 27103
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Akron, Ohio, United States, 44313
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Cincinnati, Ohio, United States, 45246
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Cleveland, Ohio, United States, 44122
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Dayton, Ohio, United States, 45419
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Zanesville, Ohio, United States, 43701
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Norman, Oklahoma, United States, 73069
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Eugene, Oregon, United States, 97404
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Beaver, Pennsylvania, United States, 15009
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Shippensburg, Pennsylvania, United States, 17257
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Tlm Medical Services
Columbia, South Carolina, United States, 29204
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Fountain Inn, South Carolina, United States, 29644
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Holston Medical Group
Bristol, Tennessee, United States, 37620
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Pmg Research Of Knoxville
Knoxville, Tennessee, United States, 37912
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Arlington Family Research Center, Inc.
Arlington, Texas, United States, 76012
Padre Coast Clinical Research
Corpus Christi, Texas, United States, 78404
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230-2548
Excel Clinical Research, Llc
Houston, Texas, United States, 77035
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North Richland Hills, Texas, United States, 76180
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San Antoinio, Texas, United States, 78229
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San Antonio, Texas, United States, 78229
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Waco, Texas, United States, 76710
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Val R. Hansen, M.D.
Bountiful, Utah, United States, 84010
Highland Clinical Research
Salt Lake City, Utah, United States, 84124
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Southwestern Vermont Med Cntr
Bennington, Vermont, United States, 05201
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Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia, United States, 23435
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Bucheon, Gyeonggi-do, Korea, Republic of, 420-717
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Daegu, Korea, Republic of, 700-721
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Cluj Napoca Cluj, Romania, 400006
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Soweto, Gauteng, South Africa, 2013
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Gauteng, Johannesburg, South Africa, 1818
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Durban, Kwa-Zulu Natal, South Africa, 4001
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Cape Town, Western Cape, South Africa, 7500
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Goodwood, Western Cape, South Africa, 7460
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Paarl, Western Cape, South Africa, 7646
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Rondebosch, Western Cape, South Africa, 7700
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Somerset West, Western Cape, South Africa, 7130
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Johannesburg, South Africa, 1829
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Johannesburg, South Africa, 2129
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: NCT01606007     History of Changes
Other Study ID Numbers: CV181-169, 2012-000679-18
Study First Received: May 23, 2012
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
Germany: Federal Institute for Drugs and Medical Devices
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Italy: Ethics Committee
Italy: The Italian Medicines Agency
India: Drugs Controller General of India
India: Institutional Review Board

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 27, 2014