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

NCT ID: NCT00263276

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

dapagliflozin

Intervention Type DRUG

Tablets, Oral, 2.5 mg, Once daily, 12 weeks.

Arm 2

Group Type EXPERIMENTAL

dapagliflozin

Intervention Type DRUG

Tablets, Oral, 5 mg, Once daily, 12 weeks.

Arm 3

Group Type EXPERIMENTAL

dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg, Once daily, 12 weeks.

Arm 4

Group Type EXPERIMENTAL

dapagliflozin

Intervention Type DRUG

Tablets, Oral, 20 mg, Once daily, 12 weeks.

Arm 5

Group Type EXPERIMENTAL

dapagliflozin

Intervention Type DRUG

Tablets, Oral, 50 mg, Once daily, 12 weeks.

Arm 6

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Tablets, Oral, 0 mg, Once daily, 12 weeks.

Arm 7

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

Tablets, Oral, \>/= 1500 mg, Once daily, 12 weeks.

Interventions

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dapagliflozin

Tablets, Oral, 2.5 mg, Once daily, 12 weeks.

Intervention Type DRUG

dapagliflozin

Tablets, Oral, 5 mg, Once daily, 12 weeks.

Intervention Type DRUG

dapagliflozin

Tablets, Oral, 10 mg, Once daily, 12 weeks.

Intervention Type DRUG

dapagliflozin

Tablets, Oral, 20 mg, Once daily, 12 weeks.

Intervention Type DRUG

dapagliflozin

Tablets, Oral, 50 mg, Once daily, 12 weeks.

Intervention Type DRUG

placebo

Tablets, Oral, 0 mg, Once daily, 12 weeks.

Intervention Type DRUG

metformin

Tablets, Oral, \>/= 1500 mg, Once daily, 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

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

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Countries

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United States Canada Mexico Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 27461213 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26894924 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19114612 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3632&filename=MB102-008%20_CSR_synopsis.pdf

MB102-008 \_CSR\_synopsis

Other Identifiers

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MB102-008

Identifier Type: -

Identifier Source: org_study_id