An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643851
• Other study ID #: MB102-021
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: January 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 994
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, Once daily, 24 weeks
• Metformin XR
Tablets, Oral, Once daily, 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Bucheon
Korea, Republic of	Local Institution	Guri-Si	Gyeonggi-Do
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul	Nowon-Gu
Korea, Republic of	Local Institution	Sungnam-Si, Gyeonggi-Do
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Ciudad De Mexico	Distrito Federal
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Merida	Yucatan
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Monterrey, Nl	Nuevo Leon
Mexico	Local Institution	Morelia	Michioacan
Mexico	Local Institution	Pachuca	Hidelgo
Mexico	Local Institution	Tampico	Tamaulipas
Mexico	Local Institution	Veracruz
Philippines	Local Institution	Cebu City
Philippines	Local Institution	Jaro Iloilo City
Philippines	Local Institution	Las Pinas City
Philippines	Local Institution	Marikina City
Philippines	Local Institution	Pasig City
Philippines	Local Institution	Quezon City
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	San Juan
Puerto Rico	Local Institution	San Juan
Puerto Rico	Local Institution	Villa Fontana
Russian Federation	Local Institution	Arkhangelsk
Russian Federation	Local Institution	Dzerzhinskiy
Russian Federation	Local Institution	Kemerovo
Russian Federation	Local Institution	Moscov
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Nizhniy Novgorod
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	Volgograd
Russian Federation	Local Institution	Voronezh
Russian Federation	Local Institution	Yaroslav
Ukraine	Local Institution	Dnepropetrovsk
Ukraine	Local Institution	Donetsk
Ukraine	Local Institution	Kiev
Ukraine	Local Institution	Kiev
Ukraine	Local Institution	Lviv
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Vinnytsya
Ukraine	Local Institution	Zhytomyr
United States	Central Florida Clinical Trials, Inc.	Altamonte Springs	Florida
United States	Gilbert Medical Research, Llc	Bethany	Oklahoma
United States	Greystone Medical Research, Llc	Birmingham	Alabama
United States	Community Health Care, Inc.	Canal Fulton	Ohio
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	Mercy Medical Group/Dba Woodlake Research	Chesterfield	Missouri
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Clinical Therapeutics Corporation	Coral Gables	Florida
United States	Safe Harbor Clinical Research	East Providence	Rhode Island
United States	Willamette Valley Clinical Studies	Eugene	Oregon
United States	Middle Tennessee Clinical Research	Fayetteville	Tennessee
United States	Commonwealth Primary Care, Pc / Fleetwood Clinical Research	Fleetwood	Pennsylvania
United States	Southland Clinical Research Center, Inc.	Fountain Valley	California
United States	Valley Research	Fresno	California
United States	Florida Research Network, Llc	Gainesville	Florida
United States	Southeastern Research Associates, Inc.	Greenville	South Carolina
United States	Winston Technology Research, Llc	Haleyville	Alabama
United States	Endocrine Associates	Houston	Texas
United States	Excel Clinical Research, Llc	Houston	Texas
United States	Non-Invasive Cardiovascular, Pa	Houston	Texas
United States	Texas Center For Drug Development	Houston	Texas
United States	Village Family Practice	Houston	Texas
United States	Wells Institute For Health Awareness	Kettering	Ohio
United States	Holston Medical Group	Kingsport	Tennessee
United States	Hudson Valley Clinical Research Center	Kingston	New York
United States	Fpa Clinical Research	Kissimmee	Florida
United States	Nextphase Clinical Trials, Inc.	Miami	Florida
United States	Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw	Midland	Texas
United States	Hill Country Medical Associates	New Braunfels	Texas
United States	Newark Physician Associates	Newark	Ohio
United States	Integris Family Care South Penn	Oklahoma City	Oklahoma
United States	Southwest Clinical Research Center, Llc	Pearland	Texas
United States	Middle Georgia Drug Study Center, Llc	Perry	Georgia
United States	Jackson Clinic	Rolling Fork	Mississippi
United States	Crescent Medical Research	Salisbury	North Carolina
United States	Covenant Clinical Research, Pa	San Antonio	Texas
United States	S.A.M. Clinical Research Center	San Antonio	Texas
United States	Biomedical Research Associates, Llc	Shippensburg	Pennsylvania
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Clinical Research Advantage, Inc.	Tempe	Arizona
United States	Deerbrook Medical Associates	Vernon Hills	Illinois
United States	Integris Family Care Yukon	Yukon	Oklahoma
United States	Physician Research, Inc.	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Mexico,  Philippines,  Puerto Rico,  Russian Federation,  Ukraine, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])	Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period.	From Baseline to Week 24
Secondary	Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])	Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model.	From Baseline to Week 24
Secondary	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c = 9% 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	Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])	Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.	From Baseline to Week 24
Secondary	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])	Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.	From Baseline to Week 24

External Links

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