A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
389
4 countries
144
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Dec 2005
144 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
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 7, 2005
CompletedFirst Posted
Study publicly available on registry
December 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedNovember 17, 2016
November 1, 2016
1.2 years
December 7, 2005
November 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in HbA1c compared to placebo.
at 12 weeks
Secondary Outcomes (1)
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
Study Arms (7)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
EXPERIMENTALArm 5
EXPERIMENTALArm 6
PLACEBO COMPARATORArm 7
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (144)
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Bayou La Batre, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Hot Springs, Arkansas, United States
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Beverly Hills, California, United States
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Long Beach, California, United States
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Los Gatos, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Redondo Beach, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Delray Beach, Florida, United States
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Holly Hill, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Augusta, Georgia, United States
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Blue Ridge, Georgia, United States
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Honolulu, Hawaii, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Arkansas City, Kansas, United States
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Baton Rouge, Louisiana, United States
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Columbia, Maryland, United States
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Elkton, Maryland, United States
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Sudbury, Massachusetts, United States
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Worcester, Massachusetts, United States
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Dearborn, Michigan, United States
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Royal Oak, Michigan, United States
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Brooklyn Center, Minnesota, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Hattiesburg, Mississippi, United States
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Jackson, Mississippi, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Scottsbluff, Nebraska, United States
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North Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Los Alamos, New Mexico, United States
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Albany, New York, United States
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Bronxville, New York, United States
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Camillus, New York, United States
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Cooperstown, New York, United States
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New Hyde Park, New York, United States
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West Seneca, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Akron, Ohio, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Mogadore, Ohio, United States
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Newark, Ohio, United States
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Zanesville, Ohio, United States
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Bethany, Oklahoma, United States
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Yukon, Oklahoma, United States
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Bend, Oregon, United States
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Eugene, Oregon, United States
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Hillsboro, Oregon, United States
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Portland, Oregon, United States
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Bensalem, Pennsylvania, United States
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Feasterville, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Morrisville, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Cumberland, Rhode Island, United States
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Johnston, Rhode Island, United States
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Anderson, South Carolina, United States
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Simpsonville, South Carolina, United States
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Summerville, South Carolina, United States
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Taylors, South Carolina, United States
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Rapid City, South Dakota, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Selmer, Tennessee, United States
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Austin, Texas, United States
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Bellaire, Texas, United States
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Bryan, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Burke, Virginia, United States
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Hampton, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Edmonds, Washington, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Milwaukee, Wisconsin, United States
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West Allis, Wisconsin, United States
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Langley, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Bathurst, New Brunswick, Canada
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Moncton, New Brunswick, Canada
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Saint John's, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Corunna, Ontario, Canada
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Etobicoke, Ontario, Canada
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Kitchener, Ontario, Canada
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Newmarket, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Drummondville, Quebec, Canada
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Granby, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Rimouski, Quebec, Canada
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Saint-Léonard, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Aguascalientes, Aguascalientes, Mexico
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Durango, Durango, Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Caguas, Puerto Rico
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Manatí, Puerto Rico
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San Juan, Puerto Rico
Related Publications (3)
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.
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: 26894924DERIVEDList 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.
PMID: 19114612DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2005
First Posted
December 8, 2005
Study Start
December 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
November 17, 2016
Record last verified: 2016-11