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

This study has been terminated.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00726505
First received: July 30, 2008
Last updated: October 14, 2016
Last verified: October 2016

July 30, 2008
October 14, 2016
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 ]
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 ]
  • Changes in liver glucose production [ Time Frame: at one day ]
  • Glucose effects on tubular markers [ Time Frame: at one day ]
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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes, NOS
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00726505
MB102-020
No
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
October 2016

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