Renal Impairment in Type 2 Diabetic Subjects

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

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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