Drug Interaction With Metformin - Full Text View

Purpose

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Condition	Intervention	Phase
Diabetes	Drug: Dapagliflozin Drug: Metformin Drug: Dapagliflozin + Metformin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Drug Reactions

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment [ Time Frame: measures taken daily throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment [ Time Frame: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period) ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	November 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Dapagliflozin Tablets, Oral, 20 mg, once daily single dose
Active Comparator: 2	Drug: Metformin Tablets, Oral, 1000 mg, once daily, single dose
Active Comparator: 3	Drug: Dapagliflozin + Metformin Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion Criteria:

Unwilling to use acceptable method of birth control
current or recent (within 1 month) smoker
abnormal liver function tests
presence of edema
history of diabetes mellitus
history of heart failure or renal insufficiency
history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
history of Hepatitis C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546741

Locations

United States, New Jersey
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, United States, 08690

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00546741 History of Changes
Other Study ID Numbers:	MB102-026
Study First Received:	October 18, 2007
Last Updated:	October 9, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Diabetes,NOS

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013