A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01483781
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    Type = exact number, unit = mg, number = 300, form = capsule, route = oral use. One encapsulated tablet once daily for up to approximately 85 days (approximately 12 weeks)
  • Placebo — DRUG
    Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)

Study Details

The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.

Key Dates

Start date
Dec 31, 2011
Status verified
Aug 2014
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in plasma volume (PV) [ Time Frame: Baseline to Week 12 of the double-blind treatment period ]

Related Studies