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

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ClinicalTrials.gov Identifier: NCT00726505
Recruitment Status : Terminated
First Posted : August 1, 2008
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes, NOS Drug: Dapagliflozin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2009
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The change in urinary glucose excretion dynamics [ Time Frame: after 7 days of treatment ]

Secondary Outcome Measures :
  1. Differences in urinary glucose between healthy and diabetic subjects [ Time Frame: at 7 days ]
  2. Changes in liver glucose production [ Time Frame: at one day ]
  3. Glucose effects on tubular markers [ Time Frame: at one day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726505


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00726505     History of Changes
Other Study ID Numbers: MB102-020
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016