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Renal Impairment in Type 2 Diabetic Subjects

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.
ClinicalTrials.gov Identifier: NCT00554450
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 5, 2007
November 7, 2007
October 17, 2016
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 ]
  • 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 ]
Same as current
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 ]
  • 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 ]
Same as current
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
Intervention Model: Parallel Assignment
Masking: None (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
Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.

*   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
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00554450
MB102-007
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
October 2016

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