A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
2 other identifiers
interventional
915
5 countries
75
Brief Summary
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin 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 Sep 2007
Typical duration for phase_3 type-2-diabetes
75 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
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 11, 2007
CompletedFirst Posted
Study publicly available on registry
September 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
May 2, 2014
CompletedOctober 20, 2015
September 1, 2015
1.2 years
September 11, 2007
February 6, 2014
September 30, 2015
Conditions
Keywords
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 (8)
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight 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 Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
From Baseline to Week 24
- +3 more secondary outcomes
Other Outcomes (6)
Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
From Baseline to end of Long-term Period (Week 102)
Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
Day 1 to Week 102
Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
Baseline to Week 102
- +3 more other outcomes
Study Arms (4)
Placebo + Metformin
PLACEBO COMPARATORParticipants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 2.5 mg + Metformin
EXPERIMENTALParticipants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 5 mg + Metformin
EXPERIMENTALParticipants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Dapagliflozin, 10 mg + Metformin
EXPERIMENTALParticipants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Interventions
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Eligibility Criteria
You may qualify if:
- Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
- 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.
You may not qualify if:
- Aspartate aminotransferase and/or alanine aminotransferase level \>3.0 times the upper limit of normal
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (75)
Clinical Research Advantage / Desert Clinical Res, Llc
Tempe, Arizona, 85282, United States
Medical Group Of Encino
Encino, California, 91436, United States
Valley Research
Fresno, California, 93720, United States
Randall Shue, D.O.
Los Angeles, California, 90023, United States
Diabetes Medical Center Of California
Northridge, California, 91325, United States
Ritchken & First M.D.'S
San Diego, California, 92117, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Raikhel, Marina
Torrance, California, 90505, United States
Express Care Clinical Res
Colorado Springs, Colorado, 80909, United States
Denver Internal Medicine
Denver, Colorado, 80209, United States
New West Physicians
Golden, Colorado, 80401, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32701, United States
Family Care Associates Of Nw Florida
Chipley, Florida, 32428, United States
Health Partners Research Foundation
Minneapolis, Minnesota, 56440, United States
Woodlake Research
Chesterfield, Missouri, 63017, United States
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101, United States
Diabetes & Endocrinology Consultants, Pc
Morehead City, North Carolina, 28557, United States
Newark Physician Associates
Newark, Ohio, 43055, United States
Integris Family Care S. Penn
Oklahoma City, Oklahoma, 73159, United States
Cumberland Valley Endocrinology Center, Llc
Carlisle, Pennsylvania, 17013, United States
Banksville Medical Pc
Pittsburgh, Pennsylvania, 15216, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Southeastern Research Assoc
Taylors, South Carolina, 29687, United States
Texas Center For Drug Development, P.A.
Houston, Texas, 77081, United States
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, 78229, United States
S.A.M. Clinical Research Center
San Antonio, Texas, 78229, United States
Optimum Clinical Research
Salt Lake City, Utah, 84102, United States
Office Of Dr. Gray
Spokane, Washington, 99216, United States
Local Institution
Buenos Aires, Buenos Aires, 1431, Argentina
Local Institution
Capital Federal, Buenos Aires, 1034, Argentina
Local Institution
Capital Federal, Buenos Aires, 1429, Argentina
Local Institution
Capital Federal, Buenos Aires, C1056ABJ, Argentina
Local Institution
Capital Federal, Buenos Aires, C1425AGC, Argentina
Local Institution
Ciudad Auton., Buenos Aires, C1505CWB, Argentina
Local Institution
Ciudad Auton, Buenos Aires, C1408INH, Argentina
Local Institution
Mar del Plata, Buenos Aires, 7600, Argentina
Local Institution
Zárate, Buenos Aires, 2800, Argentina
Local Institution
Córdoba, Córdoba Province, 5000, Argentina
Local Institution
Villa Carlos Paz, Córdoba Province, 5152, Argentina
Local Institution
Fortaleza, Ceará, 60021, Brazil
Local Institution
Itajubá, Minas Gerais, 37502, Brazil
Local Institution
Belém, Pará, 66073, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, 20211, Brazil
Local Institution
Caxias do Sul, Rio Grande do Sul, 95070, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90020090, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90035, Brazil
Local Institution
Marília, São Paulo, 17519, Brazil
Local Institution
Calgary, Alberta, T2R 0X7, Canada
Local Institution
Kelowna, British Columbia, V1Y 2H4, Canada
Local Institution
Winnipeg, Manitoba, R3E 3P4, Canada
Local Institution
Bathurst, New Brunswick, E2A 4X7, Canada
Local Institution
Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
Local Institution
St. John's, Newfoundland and Labrador, A1E 2E2, Canada
Local Institution
Sarnia, Ontario, N7T 4X3, Canada
Local Institution
Thornhill, Ontario, L4J 8L7, Canada
Local Institution
Toronto, Ontario, M4R 2G4, Canada
Local Institution
Toronto, Ontario, M9W 4L6, Canada
Local Institution
Charlottetown, Prince Edward Island, C1A 5Y9, Canada
Local Institution
Drummondville, Quebec, J2B 7T1, Canada
Local Institution
Granby, Quebec, J2G 8Z9, Canada
Local Institution
L'Ancienne-Lorette, Quebec, G2E 2X1, Canada
Local Institution
Mirabel, Quebec, J7J 2K8, Canada
Local Institution
Saint-Léonard, Quebec, H1S 3A9, Canada
Local Institution
Saskatoon, Saskatchewan, S7K 3H3, Canada
Local Institution
Saskatoon, Saskatchewan, S7K 7H9, Canada
Local Institution
Durango, Durango, 64710, Mexico
Local Institution
Guadalajara, Jalisco, 44650, Mexico
Local Institution
Guadalajara, Jalisco, 44670, Mexico
Local Institution
Df, Mexico City, 11800, Mexico
Local Institution
Guadalajara, Mexico City, 44670, Mexico
Local Institution
Zapopan, Mexico City, 45150, Mexico
Local Institution
Monterrey, Nuevo León, 64460, Mexico
Local Institution
Monterrey, Nuevo León, 64710, Mexico
Local Institution
Monterrrey, Nuevo León, 64700, Mexico
Local Institution
Tampico, Tamaulipas, 89109, Mexico
Related Publications (7)
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: 33368935DERIVEDBailey 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: 31364269DERIVEDMellander 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.
PMID: 27461213DERIVEDKohan 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: 26894924DERIVEDBailey 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.
PMID: 23425012DERIVEDBailey 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.
PMID: 20609968DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
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
September 11, 2007
First Posted
September 12, 2007
Study Start
September 1, 2007
Primary Completion
November 1, 2008
Study Completion
May 1, 2010
Last Updated
October 20, 2015
Results First Posted
May 2, 2014
Record last verified: 2015-09