- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554450
Renal Impairment in Type 2 Diabetic Subjects
The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- Advanced Clinical Research Institute
-
-
Florida
-
Miami, Florida, United States, 33169
- Elite Research Institute
-
-
Minnesota
-
St. Paul, Minnesota, United States, 55114
- Prism Research
-
-
Texas
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San Antonio, Texas, United States, 78229
- Dgd Research, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Subjects in the following groups:
Group A: Healthy Subjects with Normal Renal Function (CLcr > 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr > 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr > 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr < 30 mL/min) (and not receiving dialysis)
- Men and WOCBP, ages 18 to 79 years old
Standard Exclusion Criteria, plus:
- History of diabetic ketoacidosis
- HbA*1c > 10%
- Serum albumin < 2.0 gm/dL
- Potassium < 3.0 or > 6.0 mEq/L
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
50 mg single dose
|
Tablets, Oral, once daily
|
Experimental: Arm 2
20 mg up to 7 days
|
Tablets, Oral, once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine
Time Frame: on Days -1, 1, 4 and 10
|
on Days -1, 1, 4 and 10
|
Blood samples for serum glucose and creatinine will be collected
Time Frame: on Days -1, 1, 4 and 10 at selected timepoints
|
on Days -1, 1, 4 and 10 at selected timepoints
|
Blood and urine PK samples
Time Frame: on Days 1, 4, 10
|
on Days 1, 4, 10
|
Iohexol PK blood & urine samples for GFR assessment
Time Frame: on Day -12 to -5
|
on Day -12 to -5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AEs, vital signs
Time Frame: scr, Days -1, 1, 4-11, discharge
|
scr, Days -1, 1, 4-11, discharge
|
physical exams
Time Frame: scr, Days -12 to -5, -1, discharge
|
scr, Days -12 to -5, -1, discharge
|
ECGs
Time Frame: scr, Days,-1, 4, 7, discharge
|
scr, Days,-1, 4, 7, discharge
|
clinical labs
Time Frame: scr, Day -1, 1, 4, 6, 8, 10, discharge
|
scr, Day -1, 1, 4, 6, 8, 10, discharge
|
The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only)
Time Frame: on Days -1, 1, 4 and 10
|
on Days -1, 1, 4 and 10
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MB102-007
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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