An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
1 other identifier
interventional
994
7 countries
99
Brief Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. 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 Jun 2008
Shorter than P25 for phase_3 type-2-diabetes
99 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
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedJanuary 30, 2023
January 1, 2023
1.2 years
March 20, 2008
September 30, 2016
January 27, 2023
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 (5)
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 Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% 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 Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
Study Arms (3)
Arm 1
EXPERIMENTALDapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
Arm 2
EXPERIMENTALDapagliflozin (5 mg)
Arm 3
ACTIVE COMPARATORMetformin XR (500 mg up to 2000 mg)
Interventions
Eligibility Criteria
You may qualify if:
- Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
- Drug naive or treated with anti-diabetic medication for \< 24 weeks since original diagnosis
- C-peptide ≥ 1.0 ng/mL
- Body Mass Index ≤ 45.0 kg/m
- Serum creatinine \< 1.50 mg/dL for men or \< 1.40 mg/dL for women
You may not qualify if:
- AST and/or ALT \>3.0 times the upper limit of normal (ULN)
- Serum total bilirubin \> 2.0 mg/dL
- Creatine kinase \> 3X the upper limit of normal (ULN)
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (99)
Greystone Medical Research, Llc
Birmingham, Alabama, 35242, United States
Winston Technology Research, Llc
Haleyville, Alabama, 35565, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, 85282, United States
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708, United States
Valley Research
Fresno, California, 93720, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32701, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134, United States
Florida Research Network, Llc
Gainesville, Florida, 32605, United States
Fpa Clinical Research
Kissimmee, Florida, 34741, United States
Nextphase Clinical Trials, Inc.
Miami, Florida, 33145, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, 31069, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061, United States
Jackson Clinic
Rolling Fork, Mississippi, 39159, United States
Mercy Medical Group/Dba Woodlake Research
Chesterfield, Missouri, 63017, United States
Hudson Valley Clinical Research Center
Kingston, New York, 12401, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Community Health Care, Inc.
Canal Fulton, Ohio, 44614, United States
Wells Institute For Health Awareness
Kettering, Ohio, 45429, United States
Newark Physician Associates
Newark, Ohio, 43055, United States
Physician Research, Inc.
Zanesville, Ohio, 43701, United States
Gilbert Medical Research, Llc
Bethany, Oklahoma, 73008, United States
Integris Family Care South Penn
Oklahoma City, Oklahoma, 73159, United States
Integris Family Care Yukon
Yukon, Oklahoma, 73099, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Commonwealth Primary Care, Pc / Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Biomedical Research Associates, Llc
Shippensburg, Pennsylvania, 17257, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914, United States
Southeastern Research Associates, Inc.
Greenville, South Carolina, 29605, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Middle Tennessee Clinical Research
Fayetteville, Tennessee, 37334, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Endocrine Associates
Houston, Texas, 77004, United States
Village Family Practice
Houston, Texas, 77024, United States
Non-Invasive Cardiovascular, Pa
Houston, Texas, 77074, United States
Excel Clinical Research, Llc
Houston, Texas, 77081, United States
Texas Center For Drug Development
Houston, Texas, 77081, United States
Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw
Midland, Texas, 79705, United States
Hill Country Medical Associates
New Braunfels, Texas, 78130, United States
Southwest Clinical Research Center, Llc
Pearland, Texas, 77584, United States
Covenant Clinical Research, Pa
San Antonio, Texas, 78229, United States
S.A.M. Clinical Research Center
San Antonio, Texas, 78229, United States
Local Institution
Pachuca, Hidelgo, 42090, Mexico
Local Institution
Guadalajara, Jalisco, 44100, Mexico
Local Institution
Guadalajara, Jalisco, 44650, Mexico
Local Institution
Guadalajara, Jalisco, 44670, Mexico
Local Institution
Mexico City, Mexico City, 14000, Mexico
Local Institution
Morelia, Michioacan, 58070, Mexico
Local Institution
Monterrey, Nuevo LeĂ³n, 64000, Mexico
Local Institution
Monterrey, Nl, Nuevo LeĂ³n, 64400, Mexico
Local Institution
Tampico, Tamaulipas, 89000, Mexico
Local Institution
MĂ©rida, YucatĂ¡n, 97070, Mexico
Local Institution
Aguascalientes, 20127, Mexico
Local Institution
Durango, 34000, Mexico
Local Institution
Veracruz, 91910, Mexico
Local Institution
Cebu City, 6000, Philippines
Local Institution
Jaro Iloilo City, 5000, Philippines
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Las Piñas, 1740, Philippines
Local Institution
Marikina City, 1800, Philippines
Local Institution
Pasig, 1600, Philippines
Local Institution
Quezon City, 1100, Philippines
Local Institution
Villa Fontana, Carolina, 00983, Puerto Rico
Local Institution
Ponce, 00716, Puerto Rico
Local Institution
Ponce, 00717, Puerto Rico
Local Institution
San Juan, 00920, Puerto Rico
Local Institution
San Juan, 00926, Puerto Rico
Local Institution
Arkhangelsk, 163045, Russia
Local Institution
Dzerzhinskiy, 140091, Russia
Local Institution
Kemerovo, 650066, Russia
Local Institution
Moscov, 119048, Russia
Local Institution
Moscow, 125299, Russia
Local Institution
Nizhny Novgorod, 603018, Russia
Local Institution
Novosibirsk, 630091, Russia
Local Institution
Novosibirsk, 630117, Russia
Local Institution
Saint Petersburg, 190068, Russia
Local Institution
Saint Petersburg, 191015, Russia
Local Institution
Saratov, 410028, Russia
Local Institution
Volgograd, 400001, Russia
Local Institution
Voronezh, 394018, Russia
Local Institution
Yaroslav, 150003, Russia
Local Institution
Guri-si, Gyeonggi-do, 471-701, South Korea
Local Institution
Seoul, Nowon-Gu, 471-701, South Korea
Local Institution
Bucheon-si, 420-717, South Korea
Local Institution
Incheon, 105-760, South Korea
Local Institution
Incheon, 400-711, South Korea
Local Institution
Seoul, 137-040, South Korea
Local Institution
Sungnam-Si, Gyeonggi-Do, 463-070, South Korea
Local Institution
Dnipro, 49023, Ukraine
Local Institution
Donetsk, 83003, Ukraine
Local Institution
Kiev, 04050, Ukraine
Local Institution
Kiev, 4114, Ukraine
Local Institution
Lviv, 79010, Ukraine
Local Institution
Odesa, 65009, Ukraine
Local Institution
Odesa, 65039, Ukraine
Local Institution
Odesa, 65114, Ukraine
Local Institution
Vinnytsia, 21010, Ukraine
Local Institution
Zhytomyr, 10003, Ukraine
Related Publications (2)
Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012 May;66(5):446-56. doi: 10.1111/j.1742-1241.2012.02911.x. Epub 2012 Mar 13.
PMID: 22413962RESULTKohan 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: 26894924DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
March 20, 2008
First Posted
March 26, 2008
Study Start
June 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
January 30, 2023
Results First Posted
February 23, 2017
Record last verified: 2023-01