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Renal Mechanism of Action/Splay vs. TmG (MOA)

This study has been terminated.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00726505
First received: July 30, 2008
Last updated: February 22, 2011
Last verified: July 2010
History of Changes
  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 Mellitus
 Drug: Dapagliflozin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 1
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Subjects with T2DM - Dapagliflozin 5 mg
 Drug: Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Other Name: BMS-512148
Active Comparator: Group 2
Subjects with T2DM - Dapagliflozin 20 mg
 Drug: Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Other Name: BMS-512148
Active Comparator: Group 3
Healthy Subjects - Dapagliflozin 20 mg
 Drug: Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Other Name: BMS-512148

  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

Locations
United States, Texas
University Of Texas Health Center At San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00726505     History of Changes
Other Study ID Numbers: MB102-020
Study First Received: July 30, 2008
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013