Clinical trial NCT00643851: An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-03-26
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: 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])
timeFrame: From Baseline to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Greystone Medical Research, Llc
state: Alabama
city: Haleyville
country: United States
facility: Winston Technology Research, Llc
state: Alabama
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Fountain Valley
country: United States
facility: Southland Clinical Research Center, Inc.
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Altamonte Springs
country: United States
facility: Central Florida Clinical Trials, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Clinical Therapeutics Corporation
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network, Llc
state: Florida
city: Kissimmee
country: United States
facility: Fpa Clinical Research
state: Florida
city: Miami
country: United States
facility: Nextphase Clinical Trials, Inc.
state: Florida
city: Perry
country: United States
facility: Middle Georgia Drug Study Center, Llc
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates
state: Illinois
city: Rolling Fork
country: United States
facility: Jackson Clinic
state: Mississippi
city: Chesterfield
country: United States
facility: Mercy Medical Group/Dba Woodlake Research
state: Missouri
city: Kingston
country: United States
facility: Hudson Valley Clinical Research Center
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Canal Fulton
country: United States
facility: Community Health Care, Inc.
state: Ohio
city: Kettering
country: United States
facility: Wells Institute For Health Awareness
state: Ohio
city: Newark
country: United States
facility: Newark Physician Associates
state: Ohio
city: Zanesville
country: United States
facility: Physician Research, Inc.
state: Ohio
city: Bethany
country: United States
facility: Gilbert Medical Research, Llc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Integris Family Care South Penn
state: Oklahoma
city: Yukon
country: United States
facility: Integris Family Care Yukon
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Fleetwood
country: United States
facility: Commonwealth Primary Care, Pc / Fleetwood Clinical Research
state: Pennsylvania
city: Shippensburg
country: United States
facility: Biomedical Research Associates, Llc
state: Pennsylvania
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Greenville
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Fayetteville
country: United States
facility: Middle Tennessee Clinical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Houston
country: United States
facility: Endocrine Associates
state: Texas
city: Houston
country: United States
facility: Village Family Practice
state: Texas
city: Houston
country: United States
facility: Non-Invasive Cardiovascular, Pa
state: Texas
city: Houston
country: United States
facility: Excel Clinical Research, Llc
state: Texas
city: Houston
country: United States
facility: Texas Center For Drug Development
state: Texas
city: Midland
country: United States
facility: Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
city: Pearland
country: United States
facility: Southwest Clinical Research Center, Llc
state: Texas
city: San Antonio
country: United States
facility: Covenant Clinical Research, Pa
state: Texas
city: San Antonio
country: United States
facility: S.A.M. Clinical Research Center
state: Texas
city: Guri-Si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Local Institution
state: Nowon-Gu
city: Bucheon
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Sungnam-Si, Gyeonggi-Do
country: Korea, Republic of
facility: Local Institution
city: Ciudad De Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Pachuca
country: Mexico
facility: Local Institution
state: Hidelgo
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution
state: Michioacan
city: Monterrey, Nl
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Tampico
country: Mexico
facility: Local Institution
state: Tamaulipas
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: Veracruz
country: Mexico
facility: Local Institution
city: Cebu City
country: Philippines
facility: Local Institution
city: Jaro Iloilo City
country: Philippines
facility: Local Institution
city: Las Pinas City
country: Philippines
facility: Local Institution
city: Marikina City
country: Philippines
facility: Local Institution
city: Pasig City
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Villa Fontana
country: Puerto Rico
facility: Local Institution
city: Arkhangelsk
country: Russian Federation
facility: Local Institution
city: Dzerzhinskiy
country: Russian Federation
facility: Local Institution
city: Kemerovo
country: Russian Federation
facility: Local Institution
city: Moscov
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Nizhniy Novgorod
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Volgograd
country: Russian Federation
facility: Local Institution
city: Voronezh
country: Russian Federation
facility: Local Institution
city: Yaroslav
country: Russian Federation
facility: Local Institution
city: Dnepropetrovsk
country: Ukraine
facility: Local Institution
city: Donetsk
country: Ukraine
facility: Local Institution
city: Kiev
country: Ukraine
facility: Local Institution
city: Kiev
country: Ukraine
facility: Local Institution
city: Lviv
country: Ukraine
facility: Local Institution
city: Odessa
country: Ukraine
facility: Local Institution
city: Odessa
country: Ukraine
facility: Local Institution
city: Odessa
country: Ukraine
facility: Local Institution
city: Vinnytsya
country: Ukraine
facility: Local Institution
city: Zhytomyr
country: Ukraine
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.