Saxagliptin Treatment 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 (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
1 other identifier
interventional
1,035
6 countries
134
Brief Summary
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Jul 2005
Longer than P75 for phase_3 diabetes-mellitus-type-2
134 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
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 15, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
May 11, 2011
CompletedApril 3, 2015
March 1, 2015
1.1 years
July 15, 2005
April 12, 2011
March 16, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Hemoglobin A1c (A1C) Changes From Baseline at Week 24
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
Baseline, Week 24
A1C Changes From Baseline at Week 24 - Open Label Cohort
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
Baseline, Week 24
Secondary Outcomes (6)
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)
Baseline, Week 24
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
Week 24
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
Baseline, Week 24
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort
Baseline, Week 24
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort
Week 24
- +1 more secondary outcomes
Other Outcomes (30)
Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort
Baseline
Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort
Baseline
Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort
Baseline
- +27 more other outcomes
Study Arms (5)
Saxagliptin 2.5 mg (A)
EXPERIMENTALMetformin 500-2000 mg (as needed for rescue)
Saxagliptin 5 mg (B)
EXPERIMENTALMetformin 500-2000 mg (as needed for rescue)
Saxagliptin 10 mg (C)
EXPERIMENTALMetformin 500-2000 mg (as needed for rescue)
Placebo (D)
PLACEBO COMPARATORMetformin 500-2000 mg (as needed for rescue)
Open-Label Treatment Cohort (Direct Enrollees) (E)
EXPERIMENTALSaxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)
Interventions
Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\])
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 0 mg, daily (42 months LT)
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Drug naive
- Hemoglobin (Hb) A1c \>= 7.0% and \<= 10.0% (\>10% and \<= 12% for open label arm)
- Fasting C-peptide \>= 1 ng/mL
- Body mass index \<= 40 kg/m2
You may not qualify if:
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for Women of Child Bearing Potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (134)
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Calera, Alabama, United States
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Jonesboro, Arizona, United States
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Mesa, Arizona, United States
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Pheonix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Castle Rock, Colorado, United States
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Denver, Colorado, United States
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Loveland, Colorado, United States
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Altamonte Springs, Florida, United States
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Chipley, Florida, United States
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Cocoa Beach, Florida, United States
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Coral Gables, Florida, United States
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Fort Lauderdale, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Marianna, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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West Palm Beach, Florida, United States
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Vernon Hills, Illinois, United States
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Dubuque, Iowa, United States
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Iowa City, Iowa, United States
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Waterloo, Iowa, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Munfordville, Kentucky, United States
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New Orleans, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Chester, Maryland, United States
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Prince Frederick, Maryland, United States
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Ayer, Massachusetts, United States
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Boston, Massachusetts, United States
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Rolling Fork, Mississippi, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Middletown, New Jersey, United States
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Toms River, New Jersey, United States
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Cooperstown, New York, United States
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Greensboro, North Carolina, United States
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Huntersville, North Carolina, United States
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Sparta, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Athens, Ohio, United States
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Franklin, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Fleetwood, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Bristol, Tennessee, United States
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Morristown, Tennessee, United States
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Bryan, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Texarkana, Texas, United States
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The Colony, Texas, United States
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Salt Lake City, Utah, United States
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Virginia Beach, Virginia, United States
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Olympia, Washington, United States
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Sydney, New South Wales, Australia
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Woollongong, New South Wales, Australia
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Brisbane, Queensland, Australia
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Kippa-Ring, Queensland, Australia
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Meadowbrook, Queensland, Australia
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Adelaide, South Australia, Australia
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Woodville South, South Australia, Australia
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Perth, Western Australia, Australia
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Quesnel, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Portage la Prairie, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Bathurst, New Brunswick, Canada
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Moncton, New Brunswick, Canada
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Manuels, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Newmarket, Ontario, Canada
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Oakville, Ontario, Canada
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Peterborough, Ontario, Canada
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Sarnia, Ontario, Canada
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Strathroy, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Drummondville, Quebec, Canada
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Fleurimont, Quebec, Canada
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Gatineau, Quebec, Canada
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Granby, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Léonard, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Aguascalientes, Aguascalientes, Mexico
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Durango, Durango, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Hermosillo, Sonora, Mexico
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Carolina, Puerto Rico
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Guaynabo, Puerto Rico
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Ponce, Puerto Rico
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Rio Piedras, Puerto Rico
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San Juan, Puerto Rico
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Hualien City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
Related Publications (5)
Rosenstock J, Aguilar-Salinas C, Klein E, Nepal S, List J, Chen R; CV181-011 Study Investigators. Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes. Curr Med Res Opin. 2009 Oct;25(10):2401-11. doi: 10.1185/03007990903178735.
PMID: 19650754BACKGROUNDEsu E, Berens-Riha N, Pritsch M, Nwachuku N, Loescher T, Meremikwu M. Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria. Malar J. 2018 Jul 6;17(1):251. doi: 10.1186/s12936-018-2394-2.
PMID: 29976228DERIVEDPerl 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: 27033025DERIVEDRosenstock J, Gross JL, Aguilar-Salinas C, Hissa M, Berglind N, Ravichandran S, Fleming D. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes. Diabet Med. 2013 Dec;30(12):1472-6. doi: 10.1111/dme.12267. Epub 2013 Jul 19.
PMID: 23802840DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirschberg
- Organization
- AstraZeneca Pharmaceuticals
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
July 15, 2005
First Posted
July 21, 2005
Study Start
July 1, 2005
Primary Completion
August 1, 2006
Study Completion
February 1, 2010
Last Updated
April 3, 2015
Results First Posted
May 11, 2011
Record last verified: 2015-03