Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00316082
First received: April 18, 2006
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise


Condition Intervention Phase
Diabetes
Drug: Saxagliptin
Drug: Placebo
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Enrollment: 365
Study Start Date: June 2006
Study Completion Date: November 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Placebo Comparator: Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
Drug: Placebo
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Detailed Description:

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

  Eligibility

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Inadequate blood sugar control

Exclusion Criteria:

  • Previous treatment for diabetes
  • Current treatment with other medications to lower blood sugar
  • Major heart, liver or kidney problems
  • Women who are pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316082

  Hide Study Locations
Locations
United States, Alabama
Tomac, Inc.
Columbiana, Alabama, United States, 35051
Winston Technology, Inc.
Haleyville, Alabama, United States, 35565
United States, Arizona
Clinical Reseacrh Advantage/ Brown Family Medicine
Mesa, Arizona, United States, 85213
United States, California
Strategos Medical Group
Bakersfield, California, United States, 93311
Providence Clinical Research
Burbank, California, United States, 91505
Rx For Life, Inc
Cudahy, California, United States, 90201
Medical Group Of Encino
Encino, California, United States, 91436
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States, 92708
Valley Research
Fresno, California, United States, 93720
Diabetes Medical Center Of California
Northridge, California, United States, 91325
In Private Prictice Clinic
Pico Rivera, California, United States, 90660
San Jose Clinical Research, Inc.
San Jose, California, United States, 95128
United States, Florida
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States, 32714
Accelovance
Melbourne, Florida, United States, 32935
University Family Healthcare, Pa
Sarasota, Florida, United States, 34243
Premier Healthcare
St. Petersburg, Florida, United States, 33707
United States, Kansas
Pinnacle Medical Research
Overland Park, Kansas, United States, 66215
United States, Missouri
Kansas City University Of Medicine And Biosciences
Kansas City, Missouri, United States, 64106
Primary Care Physicians, Pc
Wentzville, Missouri, United States, 63385
United States, New Jersey
Physicians Research Center
Toms River, New Jersey, United States, 08755
United States, New York
Hudson Valley Clinical Research Center
Kingston, New York, United States, 12401
United States, North Carolina
Neem Research Group Of Charlotte
Charlotte, North Carolina, United States, 28262
Diabetes Center- East Carolina University
Greenville, North Carolina, United States, 27834
Crescent Medical Research
Salisbury, North Carolina, United States, 28144
United States, Ohio
Community Health Care, Inc.
Barberton, Ohio, United States, 44203
Clinical Research Limited
Canton, Ohio, United States, 44718
Wells Institute For Health Awareness
Kettering, Ohio, United States, 45429
Clinical Research Source, Inc
Perrysburg, Ohio, United States, 43551
United States, Oklahoma
Accelovance
Oklahoma City, Oklahoma, United States, 73112
Integris Family Care South
Oklahoma City, Oklahoma, United States, 73170
United States, Oregon
The Office Of Patricia Buchanan
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Cumberland Valley Endocrinology Center, Llc
Carlisle, Pennsylvania, United States, 17015
Fleetwood Clinical Research
Fleetwood, Pennsylvania, United States, 19522
Banksville Medical, Pc
Pittsburgh, Pennsylvania, United States, 15216
Biomedical Research Associates, Llc
Shippensburg, Pennsylvania, United States, 17257
United States, South Carolina
Middle Tyger Family Medicine
Duncan, South Carolina, United States, 29334
Southeastern Research Assoc
Taylors, South Carolina, United States, 29687
United States, Tennessee
Versoza & Ungab Internal Medicine Associates
Bartlett, Tennessee, United States, 38134
Collierville Medical Specialist
Collierville, Tennessee, United States, 38017
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Southwind Medical Specialist
Memphis, Tennessee, United States, 38125
Med-South Research
Memphis, Tennessee, United States, 38116
United States, Texas
Precision Family Medicine
Carrollton, Texas, United States, 75010
Alpha Therapy Research Center
Corpus Christi, Texas, United States, 78411
Village Family Practice
Houston, Texas, United States, 77024
Texas Center For Drug Development, P.A.
Houston, Texas, United States, 77081
Abbott Clinical Research Group, Inc
San Antonio, Texas, United States, 78224
United States, Utah
Taylor/Wade Medical
Bountiful, Utah, United States, 84010
Optimum Clinical Research
Salt Lake City, Utah, United States, 84102
United States, Virginia
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23451
United States, Washington
Spokane Internal Medicine
Spokane, Washington, United States, 99216
India
Local Institution
Manipal, Karnataka, India, 576104
Local Institution
Kochi, Kerala, India, 682026
Local Institution
Attavar, Mangalore, India, 575001
Local Institution
Sarita Vihar, New Delhi, India, 110076
Local Institution
Bangalore, India, 560034
Local Institution
Mumbai, India, 400007
Local Institution
Mumbai, India, 400021
Local Institution
Nagpur, India, 440012
Russian Federation
Local Institution
Moscov, Russian Federation, 118089
Local Institution
Moscow, Russian Federation, 115487
Local Institution
Nizhniy Novgorod, Russian Federation, 603126
Local Institution
Saint Petersburg, Russian Federation, 198013
Local Institution
Saratov, Russian Federation, 410018
Local Institution
Saratov, Russian Federation, 410054
Local Institution
Smolensk, Russian Federation, 214018
Local Institution
St.Petersburg, Russian Federation, 194156
Local Institution
Volgograd, Russian Federation, 400138
Taiwan
Local Institution
Changhua, Taiwan, 500
Local Institution
Kaohsiung County, Taiwan, 833
Local Institution
Taichung, Taiwan, 402
Local Institution
Taichung City, Taiwan, 407
Local Institution
Taipei City, Taiwan, 114
Local Institution
Tao-Yuan County, Taiwan, 333
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00316082     History of Changes
Other Study ID Numbers: CV181-038
Study First Received: April 18, 2006
Results First Received: August 17, 2009
Last Updated: November 20, 2009
Health Authority: United States: Food and Drug Administration

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 15, 2014