Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)

Part of paid clinical trials in San Diego, La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02009488
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Canagliflozin, 100 mg — DRUG
    One 100 mg capsule taken orally (by mouth) once daily
  • Canagliflozin, 300 mg — DRUG
    One 300 mg capsule taken orally (by mouth) once daily
  • Placebo — DRUG
    One placebo capsule (inactive medication) once daily.

Study Details

The purpose of this study is to assess changes from baseline in insulin sensitivity, hepatic fat content and beta cell function after approximately 24-25 weeks of treatment with canagliflozin compared to placebo in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic (blood sugar) control on metformin monotherapy or on combination therapy with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Key Dates

Start date
Sep 8, 2014
Status verified
Jan 2018
Primary completion
Jan 3, 2017
Completion
Jan 3, 2017

Study Design

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

Arms

  • Experimental: Canagliflozin (JNJ-28431754)
    Each patient will receive canagliflozin 100 mg once daily during the first 4 weeks of the 25 weeks double-blind period, then the dose may be increased to 300 mg once daily, till the end of the period.
  • Placebo Comparator: Placebo
    One placebo capsule taken orally (by mouth) once daily for approximately 28 days during the Pre-Treatment Run-In and the Baseline Periods, then during double-blind study for 178 days (approximately 24-25 weeks).

Primary Outcome Measure

Change from baseline in hepatic insulin sensitivity [ Time Frame: Baseline, 25 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
-San Diego, La JollaCalifornia--
-GainesvilleFlorida--

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By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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