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Renal Impairment in Type 2 Diabetic Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554450
First Posted: November 7, 2007
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by AstraZeneca:

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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00554450     History of Changes
Other Study ID Numbers: MB102-007
First Submitted: November 5, 2007
First Posted: November 7, 2007
Last Update Posted: October 17, 2016
Last Verified: October 2016

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