Text Size

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
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Dapagliflozin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: March 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
50 mg single dose
 Drug: Dapagliflozin
Tablets, Oral, once daily
Experimental: Arm 2
20 mg up to 7 days
 Drug: Dapagliflozin
Tablets, Oral, once daily

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554450

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Florida
Elite Research Institute
Miami, Florida, United States, 33169
United States, Minnesota
Prism Research
St. Paul, Minnesota, United States, 55114
United States, Texas
Dgd Research, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00554450     History of Changes
Other Study ID Numbers: MB102-007
Study First Received: November 5, 2007
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013