A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263276
• Other study ID #: MB102-008
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2005
• Last updated: November 16, 2016
• Start date: December 2005
• Est. completion date: February 2007

Study information

• Verified date: November 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.

• Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.

• C-peptide > 1.0 ng/ml

• Body Mass Index <= 40 kg/m2

• Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.

• No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

Exclusion Criteria:

• Unstable renal disease

• Patients with significant liver disease including chronic active hepatitis

• Within the last 6 months has had any of the following cardiovascular event:

myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.

• Subjects with clinically significant anemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
• dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
• dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
• dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
• dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
• placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks.
• metformin
Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.

Locations

Country	Name	City	State
Canada	Local institution	Bathurst	New Brunswick
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Charlottetown	Prince Edward Island
Canada	Local Institution	Corunna	Ontario
Canada	Local Institution	Drummondville	Quebec
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Etobicoke	Ontario
Canada	Local Institution	Granby	Quebec
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	Kitchener	Ontario
Canada	Local Institution	Langley	British Columbia
Canada	Local Institution	Moncton	New Brunswick
Canada	Local Institution	Newmarket	Ontario
Canada	Local Institution	Rimouski	Quebec
Canada	Local Institution	Sarnia	Ontario
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	St-Leonard	Quebec
Canada	Local Institution	St. John's	New Brunswick
Canada	Local Institution	St. John's	Newfoundland and Labrador
Canada	Local Institution	Ste-Foy	Quebec
Canada	Local Institution	Surrey	British Columbia
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Winnipeg	Manitoba
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Cuernavaca	Morelos
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Zapopan	Jalisco
Puerto Rico	Local Institution	Caguas
Puerto Rico	Local Institution	Manati
Puerto Rico	Local Institution	San Juan
United States	Local Institution	Akron	Ohio
United States	Local Institution	Albany	New York
United States	Local Institution	Albuquerque	New Mexico
United States	Local Institution	Alburquerque	New Mexico
United States	Local Institution	Anderson	South Carolina
United States	Local Institution	Arkansas City	Kansas
United States	Local Institution	Augusta	Georgia
United States	Local Institution	Austin	Texas
United States	Local Institution	Baton Rouge	Louisiana
United States	Local Institution	Bayou La Batre	Alabama
United States	Local Institution	Beachwood	Ohio
United States	Local Institution	Bellaire	Texas
United States	Local Institution	Bend	Oregon
United States	Local Institution	Bensalem	Pennsylvania
United States	Local Institution	Bethany	Oklahoma
United States	Local Institution	Beverly Hills	California
United States	Local Institution	Birmingham	Alabama
United States	Local Institution	Blue Ridge	Georgia
United States	Local Institution	Boynton Beach	Florida
United States	Local Institution	Brandon	Florida
United States	Local Institution	Bronxville	New York
United States	Local Institution	Brooklyn Center	Minnesota
United States	Local Institution	Bryan	Texas
United States	Local Institution	Burke	Virginia
United States	Local Institution	Camillus	New York
United States	Local Institution	Chandler	Arizona
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Chesterfield	Missouri
United States	Local Institution	Cincinnati	Ohio
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Colorado Springs	Colorado
United States	Local Institution	Columbia	Maryland
United States	Local Institution	Cooperstown	New York
United States	Local Institution	Cumberland	Rhode Island
United States	Local Institution	Dayton	Ohio
United States	Local Institution	Dearborn	Michigan
United States	Local Institution	Delray Beach	Florida
United States	Local Institution	Denver	Colorado
United States	Local Insitution	Edina	Minnesota
United States	Local Institution	Edmonds	Washington
United States	Local Institution	El Paso	Texas
United States	Local Institution	Elkton	Maryland
United States	Local Institution	Eugene	Oregon
United States	Local Institution	Fayetteville	Arkansas
United States	Local Institution	Feasterville	Pennsylvania
United States	Local Institution	Hampton	Virginia
United States	Local Institution	Hattiesburg	Mississippi
United States	Local Institution	High Point	North Carolina
United States	Local Institution	Hillsboro	Oregon
United States	Local Institution	Holly Hill	Florida
United States	Local Institution	Honolulu	Hawaii
United States	Local Institution	Hot Springs	Arkansas
United States	Local Institution	Houston	Texas
United States	Local Institution	Huntsville	Alabama
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Irving	Texas
United States	Local Institution	Jackson	Mississippi
United States	Local Institution	Jacksonville	Florida
United States	Local Instiuttion	Jacksonville	Florida
United States	Local Institution	Johnston	Rhode Island
United States	Local Institution	Kansas City	Missouri
United States	Local Institution	Lafayette	Indiana
United States	Local Institution	Levittown	Pennsylvania
United States	Local Institution	Long Beach	California
United States	Local Institution	Los Alamos	New Mexico
United States	Local Institution	Los Gatos	California
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	Milwaukee	Wisconsin
United States	Local Institution	Minneapolis	Minnesota
United States	Local Institution	Mission Viejo	California
United States	Local Institution	Mobile	Alabama
United States	Local Institution	Mogadore	Ohio
United States	Local Institution	Morehead City	North Carolina
United States	Local Institution	Morrisville	Pennsylvania
United States	Local Institution	Nashville	Tennessee
United States	Local Instiution	New Hyde Park	New York
United States	Local Institution	New Port Richey	Florida
United States	Local Institution	Newark	Ohio
United States	Local Institution	Norfolk	Virginia
United States	Local Institution	North Las Vegas	Nevada
United States	Local Institution	Orange	California
United States	Local Institution	Orlando	Florida
United States	Local Institution	Ormond Beach	Florida
United States	Local Institution	Portland	Oregon
United States	Local Institution	Raleigh	North Carolina
United States	Local Institution	Rapid City	South Dakota
United States	Local Institution	Reading	Pennsylvania
United States	Local Institution	Redondo Beach	California
United States	Local Institution	Renton	Washington
United States	Local Institution	Richmond	Virginia
United States	Local Institution	Royal Oak	Michigan
United States	Local Institution	Salt Lake City	Utah
United States	Local Institution	San Antonio	Texas
United States	Local Institution	San Diego	California
United States	Local Institution	Scottsbluff	Nebraska
United States	Local Institution	Selmer	Tennessee
United States	Local Institution	Simpsonville	South Carolina
United States	Local Institution	Spokane	Washington
United States	Local Institution	St. Louis	Missouri
United States	Local Institution	Sudbury	Massachusetts
United States	Local Institution	Summerville	South Carolina
United States	Local Institution	Taylors	South Carolina
United States	Local Institution	Torrance	California
United States	Local Institution	Tucson	Arizona
United States	Local Institution	Vancouver	Washington
United States	Local Institution	Virginia Beach	Virginia
United States	Local Institution	West Allis	Wisconsin
United States	Local Institution	West Seneca	New York
United States	Local Institution	Wilmington	North Carolina
United States	Local Institution	Worcester	Massachusetts
United States	Local Institution	Yukon	Oklahoma
United States	Local Institution	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in HbA1c compared to placebo.		at 12 weeks	No
Secondary	Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion		at Weeks 6 and 12	No

External Links

•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
•   MB102-008 _CSR_synopsis