Renal Impairment in Type 2 Diabetic Subjects

October 14, 2016 updated by: AstraZeneca

The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment

The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

    • 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
      • San Antonio, Texas, United States, 78229
        • Dgd Research, Inc.

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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: 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

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

Sponsor

Collaborators

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.

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

March 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 7, 2007

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

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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