A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
NCT ID: NCT00528879
Last Updated: 2015-10-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
915 participants
INTERVENTIONAL
2007-09-30
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
NCT00528372
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
NCT00736879
A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus
NCT00263276
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
NCT01646320
A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
NCT00357370
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 2.5 mg + Metformin
Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
* C-peptide ≥1.0 ng/mL
* Body mass index ≤45.0 kg/m\^2
* Serum creatinine level \<1.50 mg/dL for men or \<1.40 mg/dL for women.
Exclusion Criteria
* Serum total bilirubin level \>2 mg/dL
* Creatinine kinase level \>3 times upper limit of normal
* Symptoms of severely uncontrolled diabetes
* Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases
18 Years
77 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Advantage / Desert Clinical Res, Llc
Tempe, Arizona, United States
Medical Group Of Encino
Encino, California, United States
Valley Research
Fresno, California, United States
Randall Shue, D.O.
Los Angeles, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Ritchken & First M.D.'S
San Diego, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Raikhel, Marina
Torrance, California, United States
Express Care Clinical Res
Colorado Springs, Colorado, United States
Denver Internal Medicine
Denver, Colorado, United States
New West Physicians
Golden, Colorado, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States
Family Care Associates Of Nw Florida
Chipley, Florida, United States
Health Partners Research Foundation
Minneapolis, Minnesota, United States
Woodlake Research
Chesterfield, Missouri, United States
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States
Diabetes & Endocrinology Consultants, Pc
Morehead City, North Carolina, United States
Newark Physician Associates
Newark, Ohio, United States
Integris Family Care S. Penn
Oklahoma City, Oklahoma, United States
Cumberland Valley Endocrinology Center, Llc
Carlisle, Pennsylvania, United States
Banksville Medical Pc
Pittsburgh, Pennsylvania, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Southeastern Research Assoc
Taylors, South Carolina, United States
Texas Center For Drug Development, P.A.
Houston, Texas, United States
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, United States
S.A.M. Clinical Research Center
San Antonio, Texas, United States
Optimum Clinical Research
Salt Lake City, Utah, United States
Office Of Dr. Gray
Spokane, Washington, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Ciudad Auton., Buenos Aires, Argentina
Local Institution
Ciudad Auton, Buenos Aires, Argentina
Local Institution
Mar del Plata, Buenos Aires, Argentina
Local Institution
Zárate, Buenos Aires, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
Villa Carlos Paz, Córdoba Province, Argentina
Local Institution
Fortaleza, Ceará, Brazil
Local Institution
Itajubá, Minas Gerais, Brazil
Local Institution
Belém, Pará, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, Brazil
Local Institution
Caxias do Sul, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Marília, São Paulo, Brazil
Local Institution
Calgary, Alberta, Canada
Local Institution
Kelowna, British Columbia, Canada
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Bathurst, New Brunswick, Canada
Local Institution
Mount Pearl, Newfoundland and Labrador, Canada
Local Institution
St. John's, Newfoundland and Labrador, Canada
Local Institution
Sarnia, Ontario, Canada
Local Institution
Thornhill, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Charlottetown, Prince Edward Island, Canada
Local Institution
Drummondville, Quebec, Canada
Local Institution
Granby, Quebec, Canada
Local Institution
L'Ancienne-Lorette, Quebec, Canada
Local Institution
Mirabel, Quebec, Canada
Local Institution
Saint-Léonard, Quebec, Canada
Local Institution
Saskatoon, Saskatchewan, Canada
Local Institution
Saskatoon, Saskatchewan, Canada
Local Institution
Durango, Durango, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Df, Mexico City, Mexico
Local Institution
Guadalajara, Mexico City, Mexico
Local Institution
Zapopan, Mexico City, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Monterrrey, Nuevo León, Mexico
Local Institution
Tampico, Tamaulipas, Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Shah 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.
Bailey 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.
Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.
Kohan 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.
Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43.
Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MB102-014
Identifier Type: OTHER
Identifier Source: secondary_id
MB102-014 LT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.