Renal Impairment in Type 2 Diabetic Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT00554450
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-07
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Dapagliflozin	20 mg up to 7 days
Arm 1	Dapagliflozin	50 mg single dose

Primary Outcome Measures

Name	Time	Method
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	on Days -1, 1, 4 and 10
Blood and urine PK samples	on Days 1, 4, 10
Blood samples for serum glucose and creatinine will be collected	on Days -1, 1, 4 and 10 at selected timepoints
Iohexol PK blood & urine samples for GFR assessment	on Day -12 to -5

Secondary Outcome Measures

Name	Time	Method
ECGs	scr, Days,-1, 4, 7, discharge
AEs, vital signs	scr, Days -1, 1, 4-11, discharge
physical exams	scr, Days -12 to -5, -1, discharge
clinical labs	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)	on Days -1, 1, 4 and 10

Trial Locations

Locations (4)

Prism Research; 🇺🇸 St. Paul, Minnesota, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Elite Research Institute; 🇺🇸 Miami, Florida, United States

Dgd Research, Inc.; 🇺🇸 San Antonio, Texas, United States