Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
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
1 other identifier
interventional
365
4 countries
74
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes
Started Jun 2006
Longer than P75 for phase_3 diabetes
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2006
CompletedFirst Posted
Study publicly available on registry
April 20, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
September 25, 2009
CompletedApril 29, 2015
March 1, 2015
1.4 years
April 18, 2006
August 17, 2009
April 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Baseline, Week 24
Secondary Outcomes (4)
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24
Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Baseline, Week 24
Study Arms (5)
Saxagliptin 2.5 mg QAM (A)
EXPERIMENTALPLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
EXPERIMENTALPLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QAM (C)
EXPERIMENTALPLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QPM (D)
EXPERIMENTALPLUS open-label metformin (as needed as rescue medication)
Placebo (E)
PLACEBO COMPARATORPLUS open-label metformin (as needed as rescue medication)
Interventions
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Inadequate blood sugar control
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (74)
Tomac, Inc.
Columbiana, Alabama, 35051, United States
Winston Technology, Inc.
Haleyville, Alabama, 35565, United States
Clinical Reseacrh Advantage/ Brown Family Medicine
Mesa, Arizona, 85213, United States
Strategos Medical Group
Bakersfield, California, 93311, United States
Providence Clinical Research
Burbank, California, 91505, United States
Rx For Life, Inc
Cudahy, California, 90201, United States
Medical Group Of Encino
Encino, California, 91436, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708, United States
Valley Research
Fresno, California, 93720, United States
Diabetes Medical Center Of California
Northridge, California, 91325, United States
In Private Prictice Clinic
Pico Rivera, California, 90660, United States
San Jose Clinical Research, Inc.
San Jose, California, 95128, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32714, United States
Accelovance
Melbourne, Florida, 32935, United States
University Family Healthcare, Pa
Sarasota, Florida, 34243, United States
Premier Healthcare
St. Petersburg, Florida, 33707, United States
Pinnacle Medical Research
Overland Park, Kansas, 66215, United States
Kansas City University Of Medicine And Biosciences
Kansas City, Missouri, 64106, United States
Primary Care Physicians, Pc
Wentzville, Missouri, 63385, United States
Physicians Research Center
Toms River, New Jersey, 08755, United States
Hudson Valley Clinical Research Center
Kingston, New York, 12401, United States
Neem Research Group Of Charlotte
Charlotte, North Carolina, 28262, United States
Diabetes Center- East Carolina University
Greenville, North Carolina, 27834, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Community Health Care, Inc.
Barberton, Ohio, 44203, United States
Clinical Research Limited
Canton, Ohio, 44718, United States
Wells Institute For Health Awareness
Kettering, Ohio, 45429, United States
Clinical Research Source, Inc
Perrysburg, Ohio, 43551, United States
Accelovance
Oklahoma City, Oklahoma, 73112, United States
Integris Family Care South
Oklahoma City, Oklahoma, 73170, United States
The Office Of Patricia Buchanan
Eugene, Oregon, 97404, United States
Cumberland Valley Endocrinology Center, Llc
Carlisle, Pennsylvania, 17015, United States
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Banksville Medical, Pc
Pittsburgh, Pennsylvania, 15216, United States
Biomedical Research Associates, Llc
Shippensburg, Pennsylvania, 17257, United States
Middle Tyger Family Medicine
Duncan, South Carolina, 29334, United States
Southeastern Research Assoc
Taylors, South Carolina, 29687, United States
Versoza & Ungab Internal Medicine Associates
Bartlett, Tennessee, 38134, United States
Collierville Medical Specialist
Collierville, Tennessee, 38017, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Med-South Research
Memphis, Tennessee, 38116, United States
Southwind Medical Specialist
Memphis, Tennessee, 38125, United States
Precision Family Medicine
Carrollton, Texas, 75010, United States
Alpha Therapy Research Center
Corpus Christi, Texas, 78411, United States
Village Family Practice
Houston, Texas, 77024, United States
Texas Center For Drug Development, P.A.
Houston, Texas, 77081, United States
Abbott Clinical Research Group, Inc
San Antonio, Texas, 78224, United States
Taylor/Wade Medical
Bountiful, Utah, 84010, United States
Optimum Clinical Research
Salt Lake City, Utah, 84102, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23451, United States
Spokane Internal Medicine
Spokane, Washington, 99216, United States
Local Institution
Manipal, Karnataka, 576104, India
Local Institution
Kochi, Kerala, 682026, India
Local Institution
Attavar, Mangalore, 575001, India
Local Institution
Sarita Vihar, New Delhi, 110076, India
Local Institution
Bangalore, 560034, India
Local Institution
Mumbai, 400007, India
Local Institution
Mumbai, 400021, India
Local Institution
Nagpur, 440012, India
Local Institution
Moscov, 118089, Russia
Local Institution
Moscow, 115487, Russia
Local Institution
Nizhny Novgorod, 603126, Russia
Local Institution
Saint Petersburg, 194156, Russia
Local Institution
Saint Petersburg, 198013, Russia
Local Institution
Saratov, 410018, Russia
Local Institution
Saratov, 410054, Russia
Local Institution
Smolensk, 214018, Russia
Local Institution
Volgograd, 400138, Russia
Local Institution
Changhua, 500, Taiwan
Local Institution
Kaohsiung County, 833, Taiwan
Local Institution
Taichung, 402, Taiwan
Local Institution
Taichung, 407, Taiwan
Local Institution
Taipei, 114, Taiwan
Local Institution
Tao-Yuan County, 333, Taiwan
Related Publications (3)
Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
PMID: 27402391DERIVEDBonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.
PMID: 27033025DERIVEDFrederich R, McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.
PMID: 22828124DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirschberg
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2006
First Posted
April 20, 2006
Study Start
June 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2008
Last Updated
April 29, 2015
Results First Posted
September 25, 2009
Record last verified: 2015-03