Renal Impairment in Type 2 Diabetic Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00554450

Enrollment

Registered

2007-11-07

Start date

2006-03-31

Completion date

2008-10-31

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

Interventions

DRUGDapagliflozin

Tablets, Oral, once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
AEs, vital signs	scr, Days -1, 1, 4-11, 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
physical exams	scr, Days -12 to -5, -1, discharge
ECGs	scr, Days,-1, 4, 7, discharge
clinical labs	scr, Day -1, 1, 4, 6, 8, 10, discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026