Renal Impairment in Type 2 Diabetic Subjects

Part of paid clinical trials in Anaheim, California.

Sponsor
AstraZeneca
Study ID
NCT00554450
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Mar 31, 2006
Status verified
Oct 2016
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    50 mg single dose
  • Experimental: Arm 2
    20 mg up to 7 days

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Advanced Clinical Research InstituteAnaheimCalifornia92801-
Elite Research InstituteMiamiFlorida33169-
Prism ResearchSaint PaulMinnesota55114-
Dgd Research, Inc.San AntonioTexas78229-

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