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Clinical Trial NCT00726505 (MOA) for Diabetes, NOS is terminated. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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AstraZenecaRenal Mechanism of Action/Splay vs. TmG (MOA) Phase 1 1
Clinical Trial NCT00726505 (MOA) is designed to study Diagnostic for Diabetes, NOS. It is a Phase 1 interventional study that is terminated, having started on June 1, 2009, with plans to enroll 1 participants. Led by AstraZeneca, it is expected to complete by August 1, 2009. The latest data from ClinicalTrials.gov was last updated on October 17, 2016.
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
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
Conditions
Diabetes, NOSOther Study IDs
- MOA
- MB102-020
NCT ID Number
Start Date (Actual)
2009-06
Last Update Posted
2016-10-17
Completion Date (Estimated)
2009-08
Enrollment (Estimated)
1
Study Type
Interventional
PHASE
Phase 1
Status
Terminated
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGroup 1 Subjects with T2DM - Dapagliflozin 5 mg | Dapagliflozin Tablets, Oral, Once Daily, up to 29 days: |
Active ComparatorGroup 2 Subjects with T2DM - Dapagliflozin 20 mg | Dapagliflozin Tablets, Oral, Once Daily, up to 29 days: |
Active ComparatorGroup 3 Healthy Subjects - Dapagliflozin 20 mg | Dapagliflozin Tablets, Oral, Once Daily, up to 29 days: |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The change in urinary glucose excretion dynamics | after 7 days of treatment |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Differences in urinary glucose between healthy and diabetic subjects | at 7 days | |
Changes in liver glucose production | at one day | |
Glucose effects on tubular markers | at one day |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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
AstraZeneca772 active studies to exploreBristol-Myers Squibb448 active studies to exploreNo contact data.
1 Study Locations in 1 Countries
Texas
University Of Texas Health Center At San Antonio, San Antonio, Texas, 78229, United States