Renal Impairment in Type 2 Diabetic Subjects

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AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Dapagliflozin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00554450
MB102-007

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

40 participants in 2 patient groups

Arm 1
Experimental group
Description:
50 mg single dose
Treatment:
Drug: Dapagliflozin
Arm 2
Experimental group
Description:
20 mg up to 7 days
Treatment:
Drug: Dapagliflozin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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