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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

July 30, 2008
February 22, 2011
June 2009
August 2009   (final data collection date for primary outcome measure)
The change in urinary glucose excretion dynamics [ Time Frame: after 7 days of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726505 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Mechanism of Action/Splay vs. TmG
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus
Drug: Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Other Name: BMS-512148
  • Active Comparator: Group 1
    Subjects with T2DM - Dapagliflozin 5 mg
    Intervention: Drug: Dapagliflozin
  • Active Comparator: Group 2
    Subjects with T2DM - Dapagliflozin 20 mg
    Intervention: Drug: Dapagliflozin
  • Active Comparator: Group 3
    Healthy Subjects - Dapagliflozin 20 mg
    Intervention: Drug: Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00726505
MB102-020
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP