A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
1 other identifier
interventional
565
8 countries
133
Brief Summary
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
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-mellitus-type-2
Started Mar 2006
Longer than P75 for phase_3 diabetes-mellitus-type-2
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
September 25, 2009
CompletedApril 7, 2015
March 1, 2015
1.6 years
February 22, 2006
August 17, 2009
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Baseline, Week 24
Secondary Outcomes (3)
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 (3)
Saxagliptin plus open-label TZD (A)
EXPERIMENTALSaxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (B)
EXPERIMENTALSaxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Placebo plus open-label TZD (C)
PLACEBO COMPARATORPlacebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Interventions
Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)
Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)
Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Eligibility Criteria
You may qualify if:
- Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
- Hemoglobin A1c (HbA1c) \> = 7.0% and \< = 10.5%
- Body mass index \< = 45kg/m2
- Fasting C-peptide \> = 1 ng/mL
You may not qualify if:
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine \> = 2.0 mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (133)
Winston Technology, Inc.
Haleyville, Alabama, 35565, United States
Sunbelt Research Group, Llc
Mobile, Alabama, 36606, United States
Iicr, Inc.
Ozark, Alabama, 36360, United States
Clinical Research Advantage, Inc
Mesa, Arizona, 85213, United States
Nea Clinic
Jonesboro, Arkansas, 72401, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, 72205, United States
Impact Clinical Trials
Beverly Hills, California, 90211, United States
Lovelace Scientific Resources, Inc.
Beverly Hills, California, 90211, United States
Medical Group Of Encino
Encino, California, 91436, United States
Marin Endocrine Care And Research, Inc.
Greenbrae, California, 94904, United States
Del Rosario Medical Clinic, Inc.
Huntington Park, California, 90255, United States
Loma Linda Va Healthcare Systems
Loma Linda, California, 92357, United States
Peak Health Medical Group
Los Angeles, California, 90025, United States
Richard Cherlin, Md
Los Gatos, California, 95032, United States
Mission Internal Medical Group
Mission Viejo, California, 92691, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Denver Internal Medicine Group
Denver, Colorado, 80209, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Phoenix Internal Medicine Associates, Llc
Waterbury, Connecticut, 06708, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32714, United States
Southern Family Healthcare, Pa
Chipley, Florida, 32428, United States
Doctors Medical Center Of Walton County
DeFuniak Springs, Florida, 32435, United States
Horizon Institute For Clinical Research
Hollywood, Florida, 33021, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32205, United States
Panhandle Family Care Associates
Marianna, Florida, 32446, United States
Nextphase Clinical Trials, Inc
Miami, Florida, 33145, United States
Baptist Diabetes Associates
Miami, Florida, 33156, United States
Heart & Vascular Center Research, Inc.
Sarasota, Florida, 34239, United States
Alan B. Miller, Md
Dunwoody, Georgia, 30338, United States
Marietta Clinical Research, Inc.
Marietta, Georgia, 30060, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
D. Thomas Rogers, Md, Facs
Kahului, Hawaii, 96732, United States
Southeast Idaho Family Practice
Idaho Falls, Idaho, 83404, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Physicians Research Group
Indianapolis, Indiana, 46250, United States
Northwest Indiana Center For Clinical Research
Valparaiso, Indiana, 46383, United States
Lipid Research Clinic
Iowa City, Iowa, 52242, United States
Professional Research Network Of Kansas
Wichita, Kansas, 67203, United States
Mouhaffel, Assad H.
West Monroe, Louisiana, 71291, United States
Promed Physicians Family Practice
Portage, Michigan, 49024, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Radiant Research Las Vegas
Las Vegas, Nevada, 89146, United States
Nevada Alliance Against Diabetes
North Las Vegas, Nevada, 89030, United States
Office Of Ammar Bazerbashi, Md
Holmdel, New Jersey, 07733, United States
Urgentmed, P.C.
South Bound Brook, New Jersey, 08880, United States
Medical Research Associates Of Charlotte, Inc.
Charlotte, North Carolina, 28211, United States
Carolina Pharmaceutical Research
Statesville, North Carolina, 28625, United States
Community Health Care
Canal Fulton, Ohio, 44614, United States
Clinical Research Limited
Canton, Ohio, 44718, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Providence Health Partners - Center For Clinical Research
Dayton, Ohio, 45439, United States
Holzer Clinic
Gallipolis, Ohio, 45631, United States
Wells Institute For Health Awareness
Kettering, Ohio, 45429, United States
David Witkin, Md
Eugene, Oregon, 97401, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438, United States
Family Medical Associates
Levittown, Pennsylvania, 19056, United States
Banksville Medical Pc
Pittsburgh, Pennsylvania, 15216, United States
Three Rivers Medical Associates, Pa
Columbia, South Carolina, 29201, United States
Radiant Research, Greer
Greer, South Carolina, 29651, United States
Upstate Pharmaceutical Research
Simpsonville, South Carolina, 29681, United States
East Tennessee Medical Group
Alcoa, Tennessee, 37701, United States
Healthstar Physicians
Morristown, Tennessee, 37813, United States
Hayes Endocrine And Diabetes Center
Nashville, Tennessee, 37209, United States
Capital Medical Clinic, Llp
Austin, Texas, 78705, United States
Texas Diabetes And Endocrinology, P.A.
Austin, Texas, 78731, United States
Radiant Research-Austin
Austin, Texas, 78752, United States
Priscilla Hollander, Md, Phd
Dallas, Texas, 75246, United States
The Medical Group Of Texas
Fort Worth, Texas, 76104, United States
Mobley Research Center
Houston, Texas, 77024, United States
Family Physician, Pa
Houston, Texas, 77074, United States
Mapleridge Medical Center
Houston, Texas, 77081, United States
Diabetes Center Of The Southwest
Midland, Texas, 79705, United States
Pearland Primary Care Associates, Llp
Pearland, Texas, 77584, United States
Med-Cure
Rosenberg, Texas, 77471, United States
Radiant Research San Antonio
San Antonio, Texas, 78229, United States
S.A.M. Clinical Research Center
San Antonio, Texas, 78229, United States
Collom And Carney Clinic
Texarkana, Texas, 75503, United States
National Clinical Research, Inc.
Richmond, Virginia, 23294, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23451, United States
Local Institution
Belgrano, Buenos Aires, C1426EGP, Argentina
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Buenos Aires, Buenos Aires, C1408INH, Argentina
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Chacabuco, Buenos Aires, B6740CWC, Argentina
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Ciudad Auton., Buenos Aires, C1505CWB, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Morón, Buenos Aires, B17081FF, Argentina
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Mendoza, Mendoza Province, M5519XAC, Argentina
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Rosario, Santa Fe Province, S2000CVD, Argentina
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Lanus Este, Tucumán Province, 1824, Argentina
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Buenos Aires, C1425AGC, Argentina
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St. John's, Newfoundland and Labrador, A1E 2C2, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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St. Catharines, Ontario, L2R 7P3, Canada
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Saint-Léonard, Quebec, H1S 3A9, Canada
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Ste-Foy, Quebec, G1V 4G2, Canada
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Saskatoon, Saskatchewan, S7K 3H3, Canada
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Bangalore, 560010, India
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Bangalore, 560054, India
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Chennai, 600010, India
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Chennai, 600013, India
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Chennai, 600086, India
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Chennai, 680004, India
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Hariyāna, 132001, India
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Hyderabad, 500082, India
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Indore, 452001, India
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Maharashtra, 411011, India
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Mangalore, 575001, India
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Mumbai, 400021, India
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Mumbai, 400067, India
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Pune, 411011, India
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Vellore, 632004, India
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Aguascalientes, Aguascalientes, 20232, Mexico
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Chichuahua, Chihuahua, 31000, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Angeles Del Pedregal, Mexico City, 10700, Mexico
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Michoacan, Morelos, 58000, Mexico
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Monterrey, Nuevo León, 66260, Mexico
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La Victoria, Lima region, 13, Peru
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Lima Cercado, Lima region, 1, Peru
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Miraflores, Lima region, 18, Peru
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San Isidro, Lima region, 27, Peru
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San Martín de Porres, Lima region, 31, Peru
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Santiago de Surco, Lima region, 33, Peru
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Cebu City, 1600, Philippines
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Cebu City, 6000, Philippines
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Iloilo City, 5000, Philippines
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Las Piñas, 1740, Philippines
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Pasig, 1600, Philippines
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Carolina, 00983, Puerto Rico
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Ponce, 00716, Puerto Rico
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Ponce, 00717, Puerto Rico
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Rio Piedras, 00926, Puerto Rico
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San Juan, 00920, Puerto Rico
Related Publications (6)
Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. doi: 10.1210/jc.2009-0550. Epub 2009 Oct 28.
PMID: 19864452BACKGROUNDPerl 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: 27033025DERIVEDKaryekar 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: 21680990DERIVEDHollander PL, Li J, Frederich R, Allen E, Chen R; CV181013 Investigators. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2011 Apr;8(2):125-35. doi: 10.1177/1479164111404575.
PMID: 21562064DERIVED
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
February 22, 2006
First Posted
February 24, 2006
Study Start
March 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2008
Last Updated
April 7, 2015
Results First Posted
September 25, 2009
Record last verified: 2015-03