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

October 14, 2016 updated by: AstraZeneca

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Subjects with T2DM - Dapagliflozin 5 mg
Drug: Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Other Names:
  • BMS-512148
Active Comparator: Group 2
Subjects with T2DM - Dapagliflozin 20 mg
Drug: Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Other Names:
  • BMS-512148
Active Comparator: Group 3
Healthy Subjects - Dapagliflozin 20 mg
Drug: Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Other Names:
  • BMS-512148

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (Estimate)

August 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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