Clinical trial NCT00263276: A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-12-08
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
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 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


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in HbA1c compared to placebo.
timeFrame: at 12 weeks
Secondary outcomes:
measure: 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
timeFrame: at Weeks 6 and 12
Other outcomes:
Locations:
city: Bayou La Batre
country: United States
facility: Local Institution
state: Alabama
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Huntsville
country: United States
facility: Local Institution
state: Alabama
city: Mobile
country: United States
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state: Alabama
city: Chandler
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Fayetteville
country: United States
facility: Local Institution
state: Arkansas
city: Hot Springs
country: United States
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state: Arkansas
city: Beverly Hills
country: United States
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state: California
city: Long Beach
country: United States
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state: California
city: Los Gatos
country: United States
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state: California
city: Mission Viejo
country: United States
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state: California
city: Orange
country: United States
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state: California
city: Redondo Beach
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: Torrance
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Denver
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state: Colorado
city: Boynton Beach
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state: Florida
city: Brandon
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state: Florida
city: Delray Beach
country: United States
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state: Florida
city: Holly Hill
country: United States
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state: Florida
city: Jacksonville
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city: Jacksonville
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city: New Port Richey
country: United States
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city: Orlando
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city: Ormond Beach
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state: Florida
city: Augusta
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state: Georgia
city: Blue Ridge
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city: Honolulu
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state: Hawaii
city: Indianapolis
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state: Indiana
city: Lafayette
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city: Arkansas City
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state: Kansas
city: Baton Rouge
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state: Louisiana
city: Columbia
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state: Maryland
city: Elkton
country: United States
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state: Maryland
city: Sudbury
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state: Massachusetts
city: Worcester
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state: Massachusetts
city: Dearborn
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state: Michigan
city: Royal Oak
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city: Brooklyn Center
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city: Edina
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city: Minneapolis
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city: Jackson
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city: Chesterfield
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city: Kansas City
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city: St. Louis
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city: North Las Vegas
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city: Albuquerque
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city: Alburquerque
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city: Albany
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city: Bronxville
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city: Camillus
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city: Cooperstown
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city: New Hyde Park
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state: New York
city: West Seneca
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state: New York
city: Charlotte
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state: North Carolina
city: High Point
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city: Morehead City
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city: Raleigh
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city: Yukon
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city: Eugene
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city: Portland
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city: Bensalem
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state: Pennsylvania
city: Feasterville
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state: Pennsylvania
city: Levittown
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city: Morrisville
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city: Reading
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state: Pennsylvania
city: Cumberland
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state: Rhode Island
city: Johnston
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state: Rhode Island
city: Anderson
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state: South Carolina
city: Simpsonville
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city: Summerville
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state: South Carolina
city: Taylors
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city: Rapid City
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city: Memphis
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city: Nashville
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city: Selmer
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city: Bellaire
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city: Burke
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state: Virginia
city: Hampton
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city: Norfolk
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city: Richmond
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state: Virginia
city: Virginia Beach
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state: Virginia
city: Edmonds
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state: Washington
city: Renton
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city: Vancouver
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city: Milwaukee
country: United States
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state: Wisconsin
city: West Allis
country: United States
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state: Wisconsin
city: Calgary
country: Canada
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state: Alberta
city: Edmonton
country: Canada
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state: Alberta
city: Langley
country: Canada
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state: British Columbia
city: Surrey
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Bathurst
country: Canada
facility: Local institution
state: New Brunswick
city: Moncton
country: Canada
facility: Local Institution
state: New Brunswick
city: St. John's
country: Canada
facility: Local Institution
state: New Brunswick
city: St. John's
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Corunna
country: Canada
facility: Local Institution
state: Ontario
city: Etobicoke
country: Canada
facility: Local Institution
state: Ontario
city: Kitchener
country: Canada
facility: Local Institution
state: Ontario
city: Newmarket
country: Canada
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state: Ontario
city: Sarnia
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Charlottetown
country: Canada
facility: Local Institution
state: Prince Edward Island
city: Drummondville
country: Canada
facility: Local Institution
state: Quebec
city: Granby
country: Canada
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state: Quebec
city: Greenfield Park
country: Canada
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state: Quebec
city: Rimouski
country: Canada
facility: Local Institution
state: Quebec
city: St-Leonard
country: Canada
facility: Local Institution
state: Quebec
city: Ste-Foy
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: Caguas
country: Puerto Rico
facility: Local Institution
city: Manati
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009 Apr;32(4):650-7. doi: 10.2337/dc08-1863. Epub 2008 Dec 29.