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Renal Impairment in Type 2 Diabetic Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00554450
First received: November 5, 2007
Last updated: June 6, 2014
Last verified: June 2014

November 5, 2007
June 6, 2014
March 2006
October 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00554450 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Dapagliflozin
Tablets, Oral, once daily
  • Experimental: Arm 1
    50 mg single dose
    Intervention: Drug: Dapagliflozin
  • Experimental: Arm 2
    20 mg up to 7 days
    Intervention: Drug: Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554450
MB102-007
No
Study Director, Bristol-Myers Squibb
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
June 2014

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