Add-on to Thiazolidinedione (TZD) Failures
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
1 other identifier
interventional
972
9 countries
89
Brief Summary
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Jul 2008
Typical duration for phase_3 type-2-diabetes
89 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
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedFebruary 23, 2017
January 1, 2017
1.5 years
May 22, 2008
October 6, 2016
January 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
From Baseline to Week 24
Secondary Outcomes (6)
Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
- +1 more secondary outcomes
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
- All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
- C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- Body Mass Index ≤ 45.0 kg/m²
You may not qualify if:
- AST and /or ALT \> 2.5 times the upper limit of normal
- Serum total bilirubin \> 2 mg/dL (34.2 µmol/L)
- Creatinine kinase \> 3.0 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- Serum creatinine ≥ 2.0 mg/dL
- Calculated Cr-Clearance \< 50 ml/min (calculated by Cockroft-Gault formula)
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Astra Zeneca, Bristol-Myers Squibbcollaborator
Study Sites (89)
Pinnacle Research Group, Llc
Anniston, Alabama, 36207, United States
Iicr
Ozark, Alabama, 36360, United States
43rd Medical Associates, P.C.
Phoenix, Arizona, 85051, United States
Clinical Research Advantage Inc / Desert Clinical Res, Llc
Tempe, Arizona, 85282, United States
Clinical Research Advantage, Inc
Tempe, Arizona, 85282, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, 72205, United States
Searcy Medical Center
Searcy, Arkansas, 72143, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92626, United States
Marin Endocrine Care And Research, Inc.
Greenbrae, California, 94904, United States
Torrance Clinical Research
Lomita, California, 90717, United States
Randall Shue, D.O.
Los Angeles, California, 90023, United States
Diabetes Medical Center Of California
Northridge, California, 91325, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Avastra Clinical Trials
Redlands, California, 92373, United States
Sierra Clinical Research
Roseville, California, 95661, United States
Ritchken & First M.D.'S
San Diego, California, 92117, United States
Advantage Clinical Research
Santa Ana, California, 92701, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Diabetes Research Center
Tustin, California, 92780, United States
Aurora Family Medicine Center, P.C.
Aurora, Colorado, 80012, United States
Denver Internal Medicine
Denver, Colorado, 80209, United States
Central Florida Clinical Trials
Altamonte Springs, Florida, 32701, United States
Health First Clinical Research Group, Inc.
Chipley, Florida, 32428, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134, United States
Westside Center For Clinical Research
Jacksonville, Florida, 32205, United States
Panhandle Family Care Associates
Marianna, Florida, 32446, United States
Baptist Diabetes Associates, Pa
Miami, Florida, 33156, United States
Suncoast Clinical Res Inc.
New Port Richey, Florida, 34652, United States
Stone Mountain Clinical Research
Stone Mountain, Georgia, 30088, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Northwest Indiana Center For Clinical Research
Valparaiso, Indiana, 46383, United States
Professional Research Network Of Kansas
Wichita, Kansas, 67203, United States
St. Mary'S Center For Diabetes And Endocrinology
Grand Rapids, Michigan, 49503, United States
Endocrine Research Associates
Jackson, Mississippi, 39216, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Danny W. Jackson P.A.
Rolling Fork, Mississippi, 39159, United States
Association Of International Professionals
Las Vegas, Nevada, 89101, United States
Physicians Research Center
Toms River, New Jersey, 08755, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Metrolina Internal Medicine
Charlotte, North Carolina, 28204, United States
The Center For Nutrition & Preventive Medicine, Pllc
Charlotte, North Carolina, 28277, United States
Northstate Clinical Research
Lenoir, North Carolina, 28645, United States
New Hanover Medical Research
Wilmington, North Carolina, 28401, United States
Providence Health Partners - Center For Clinical Research
Dayton, Ohio, 45439, United States
Physician Research, Inc.
Zanesville, Ohio, 43701, United States
Family Medical Associates
Levittown, Pennsylvania, 19056, United States
Banksville Medical, Pc
Pittsburgh, Pennsylvania, 15216, United States
Brookside Family Practice & Pediatrics
Pottstown, Pennsylvania, 19464, United States
Columbia Clinical Research, Inc.
Columbia, South Carolina, 29201, United States
Southeastern Research Associates, Inc.
Taylors, South Carolina, 29687, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230, United States
Village Family Practice
Houston, Texas, 77024, United States
Office Of Dr. Michelle Zaniewski Singh
Houston, Texas, 77090, United States
Diabetes & Glandular Disease Research Assoc,, Inc.
San Antonio, Texas, 78229, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
William L. Gray, Md
Spokane, Washington, 99216, United States
Local Institution
Buenos Aires, Buenos Aires, B1708IFF, Argentina
Local Institution
Ciudad Auton, Buenos Aires, C1408INH, Argentina
Local Institution
Zárate, Buenos Aires, 2800, Argentina
Local Institution
Córdoba, Córdoba Province, 5000, Argentina
Local Institution
Winnipeg, Manitoba, R3K 0Y8, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
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Halifax, Nova Scotia, B3K 5R3, Canada
Local Institution
Sarnia, Ontario, N7T 4X3, Canada
Local Institution
Toronto, Ontario, M8V 3X8, Canada
Local Institution
Mirabel, Quebec, J7J 2K8, Canada
Local Institution
Hariyāna, 132001, India
Local Institution
Mumbai, 400007, India
Local Institution
Vellore, 632004, India
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Chihuahua City, Chihuahua, 31020, Mexico
Local Institution
Guadalajara, Jalisco, 44100, Mexico
Local Institution
Guadalajara, Jalisco, 44670, Mexico
Local Institution
Zapopan, Jalisco, 45200, Mexico
Local Institution
Monterrey, Nuevo León, 64240, Mexico
Local Institution
Monterrey, Nl, Nuevo León, 64400, Mexico
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Veracruz, Veracruz, 91700, Mexico
Local Institution
Mérida, Yucatán, 97210, Mexico
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Lima, Lima Province, 09, Peru
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Lima, Lima Province, 17, Peru
Local Institution
Lima, Lima Province, 31, Peru
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Cebu City, 6000, Philippines
Local Institution
Manila, 1000, Philippines
Local Institution
Pasig, 1600, Philippines
Local Institution
Ponce, 00717, Puerto Rico
Local Institution
Changhua, 500, Taiwan
Local Institution
Taichung, 43303, Taiwan
Local Institution
Taipei, 110, Taiwan
Related Publications (4)
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVEDShah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
PMID: 33368935DERIVEDKohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
PMID: 26894924DERIVEDRosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012 Jul;35(7):1473-8. doi: 10.2337/dc11-1693. Epub 2012 Mar 23.
PMID: 22446170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Maria Langkilde
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
May 22, 2008
First Posted
May 26, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2010
Study Completion
June 1, 2010
Last Updated
February 23, 2017
Results First Posted
February 23, 2017
Record last verified: 2017-01