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
  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:


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:
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 April 15, 2014