Renal Impairment in Type 2 Diabetic Subjects

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00554450

First received: November 5, 2007

Last updated: December 7, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 5, 2007

Last Updated Date

December 7, 2010

Start Date ^ICMJE

March 2006

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: on Days -1, 1, 4 and 10 ] [ Designated as safety issue: No ]
Blood samples for serum glucose and creatinine will be collected [ Time Frame: on Days -1, 1, 4 and 10 at selected timepoints ] [ Designated as safety issue: No ]
Blood and urine PK samples [ Time Frame: on Days 1, 4, 10 ] [ Designated as safety issue: No ]
Iohexol PK blood & urine samples for GFR assessment [ Time Frame: on Day -12 to -5 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00554450 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AEs, vital signs [ Time Frame: scr, Days -1, 1, 4-11, discharge ] [ Designated as safety issue: Yes ]
physical exams [ Time Frame: scr, Days -12 to -5, -1, discharge ] [ Designated as safety issue: No ]
ECGs [ Time Frame: scr, Days,-1, 4, 7, discharge ] [ Designated as safety issue: No ]
clinical labs [ Time Frame: scr, Day -1, 1, 4, 6, 8, 10, discharge ] [ Designated as safety issue: No ]
The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only) [ Time Frame: on Days -1, 1, 4 and 10 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Renal Impairment in Type 2 Diabetic Subjects

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Dapagliflozin

Tablets, Oral, once daily

Study Arm (s)

Experimental: Arm 1
50 mg single dose

Intervention: Drug: Dapagliflozin
Experimental: Arm 2
20 mg up to 7 days

Intervention: Drug: Dapagliflozin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00554450

Other Study ID Numbers ^ICMJE

MB102-007

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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