A Study of Two Methods for Determining the Renal Threshold for Glucose in Patients With Type 2 Diabetes Mellitus

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01273558
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    One 100 mg capsule taken orally (by mouth) on Days Days 1-8

Study Details

The purpose of this study is to compare the results from two methods used to determine the renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at which appreciable amounts of glucose appear in the urine) in untreated patients with type 2 diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg once-daily canigliflozin for 8 days.

Key Dates

Start date
Jan 31, 2011
Status verified
Apr 2013
Completion
Jul 31, 2011

Study Design

Enrollment
28 participants (actual)
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Part 1: no Intervention
    In Part 1 of the study, patients will not receive any study drug.
  • Experimental: Part 2: canagliflozin
    In Part 2 of the study, patients will receive canagliflozin once daily on Days 1 through 8.

Primary Outcome Measure

RTG values using the MMTT and the stepwise hyperglycemic clamp methods [ Time Frame: On Days 1 and 2 (Part 1) ]

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