Renal Mechanism of Action/Splay vs. TmG - Full Text View

Purpose

The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus

Condition	Intervention	Phase
Diabetes, NOS	Drug: Dapagliflozin	Phase I

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Official Title:	Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The change in urinary glucose excretion dynamics [ Time Frame: after 7 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Differences in urinary glucose between healthy and diabetic subjects [ Time Frame: at 7 days ] [ Designated as safety issue: No ]
Changes in liver glucose production [ Time Frame: at one day ] [ Designated as safety issue: No ]
Glucose effects on tubular markers [ Time Frame: at one day ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator Subjects with T2DM - Dapagliflozin 5 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, up to 29 days:
Group 2: Active Comparator Subjects with T2DM - Dapagliflozin 20 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, up to 29 days:
Group 3: Active Comparator Healthy Subjects - Dapagliflozin 20 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, up to 29 days:

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male and female subjects
Age 18 to 65 years
BMI 18 to 35 kg/m2
Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
No evidence of impaired renal function

Exclusion Criteria:

Unwilling or unable to use an acceptable method of birth control
Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
Exposure to insulin
Use of exclusionary concomitant medications
Evidence of significant kidney disease or any other significant medical or psychiatric disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726505

Contacts


Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations


United States, Texas
	Local Institution	Not yet recruiting
	San Antonio, Texas, United States, 78229
	Contact: Site 001

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB102-020
First Received:	July 30, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00726505
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Healthy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Bristol-Myers Squibb AstraZeneca
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00726505