Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"
1 other identifier
interventional
1,462
9 countries
152
Brief Summary
The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone
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 Aug 2005
Longer than P75 for phase_3 diabetes-mellitus-type-2
152 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
July 18, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
April 8, 2011
CompletedApril 29, 2015
March 1, 2015
1.2 years
July 18, 2005
March 15, 2011
April 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Mean change from baseline is adjusted for baseline value.
Baseline, Week 24
Secondary Outcomes (3)
Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
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
Other Outcomes (18)
Overall Summary of Adverse Events During ST+LT Treatment Period
AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.
Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period
Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
- +15 more other outcomes
Study Arms (4)
Saxagliptin + Metformin (A)
EXPERIMENTALPioglitazone 15-45 mg (as needed for rescue)
Saxagliptin + Metformin (B)
EXPERIMENTALPioglitazone 15-45 mg (as needed for rescue)
Saxagliptin + Metformin (C)
EXPERIMENTALPioglitazone 15-45 mg (as needed for rescue)
Placebo+ Metformin (D)
PLACEBO COMPARATORPioglitazone 15-45 mg (as needed for rescue)
Interventions
Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 15 - 45 mg (as needed for rescue)
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
- HbA1c \>= 7.0% and \<= 10.0 %
- Body mass index \<= 40 kg/m2
- Fasting C-peptide \>= 1 ng/dL
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 females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (152)
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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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Haleyville, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Sherwood, Arkansas, United States
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Encino, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Northridge, California, United States
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Orange, California, United States
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Roseville, California, United States
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Sacramento, 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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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Golden, 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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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Marianna, Florida, United States
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Miami, 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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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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Vernon Hills, Illinois, United States
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Elkhart, Indiana, United States
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Lafayette, Indiana, United States
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Iowa City, Iowa, United States
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Waterloo, Iowa, United States
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Topeka, 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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Boston, Massachusetts, United States
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Kansas City, 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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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Morehead City, North Carolina, United States
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Salisbury, North Carolina, United States
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Sparta, North Carolina, United States
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Wilmington, 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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Columbus, Ohio, United States
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Lyndhurst, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Carlisle, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Levittown, 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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Duncan, South Carolina, United States
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Bristol, Tennessee, United States
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Austin, Texas, United States
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Bryan, Texas, United States
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Carrollton, Texas, United States
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Dallas, 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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Salt Lake City, Utah, United States
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Hampton, Virginia, United States
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Virginia Beach, Virginia, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Buenos Aires, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Rosario, Santa Fe Province, Argentina
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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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Fortaleza, Ceará, Brazil
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Belém, Pará, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, São Paulo, Brazil
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Marília, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Brandon, Manitoba, 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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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Aylmer, Ontario, Canada
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London, Ontario, Canada
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Oakville, Ontario, Canada
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Sarnia, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Woodstock, 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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Longueuil, Quebec, Canada
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Saint-Léonard, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Santiago, Santiago Metropolitan, Chile
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Durango, Durango, Mexico
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Celaya, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Distrito Federal, Mexico City, Mexico
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Morelia, Michioacan, Mexico
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Monterrey, Nuevo León, Mexico
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Hermosillo, Sonora, Mexico
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Mérida, Yucatán, Mexico
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Carolina, Puerto Rico
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Ponce, Puerto Rico
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Rio Pieoras, 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 (7)
DeFronzo RA, Hissa MN, Garber AJ, Luiz Gross J, Yuyan Duan R, Ravichandran S, Chen RS; Saxagliptin 014 Study Group. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009 Sep;32(9):1649-55. doi: 10.2337/dc08-1984. Epub 2009 May 28.
PMID: 19478198BACKGROUNDBailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
PMID: 31364269DERIVEDPerl 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: 23802840DERIVEDKaryekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.
PMID: 23795975DERIVEDKaryekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.
PMID: 21680990DERIVED
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 18, 2005
First Posted
July 21, 2005
Study Start
August 1, 2005
Primary Completion
October 1, 2006
Study Completion
February 1, 2010
Last Updated
April 29, 2015
Results First Posted
April 8, 2011
Record last verified: 2015-03