Renal Impairment in Type 2 Diabetic Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

50 mg single dose

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, once daily

Arm 2

20 mg up to 7 days

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, once daily

Interventions

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Dapagliflozin

Tablets, Oral, once daily

Intervention Type DRUG

Eligibility Criteria

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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