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Trial Details for Trial MB102-020

Collaborator: AstraZeneca

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

Overall Recruitment Status: Terminated

Condition(s): Diabetes Mellitus

Intervention(s): Dapagliflozin

Phase: 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

Primary Outcome Measures:

  • The change in urinary glucose excretion dynamics
       Time Frame : after 7 days of treatment


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



    • Arms Assigned Interventions
    Group 1:Active Comparator
    Subjects with T2DM - Dapagliflozin 5 mg    		 Drug:Dapagliflozin
      Tablets, Oral, Once Daily, up to 29 days:
    Group 2:Active Comparator
    Subjects with T2DM - Dapagliflozin 20 mg    		 Drug:Dapagliflozin
      Tablets, Oral, Once Daily, up to 29 days:
    Group 3:Active Comparator
    Healthy Subjects - Dapagliflozin 20 mg    		 Drug:Dapagliflozin
      Tablets, Oral, Once Daily, up to 29 days:


    Estimated Enrollment: 1

    Study Start Date: June 2009

    Estimated Primary Completion Date: August 2009

    Download Date: ClinicalTrials.gov processed this data on June 17, 2013

    Link Text: Link to the current ClinicalTrials.gov record.

    URL: http://clinicaltrials.gov/show/NCT00726505

    Eligibility

    Accepts Healthy Volunteers: Yes

    Minimum age: 18 Years

    Maximum age: 65 Years

    Gender(s): Both

    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

    General Contact Information

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        Health Authority :   United States: Food and Drug Administration