A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01381900
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
  • Canagliflozin 100mg — DRUG
    Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
  • Canagliflozin 300mg — DRUG
    Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
  • Metformin — DRUG
    The participant's stable dose of background therapy of metformin should be continued throughout the study.
  • Sulphonylurea — DRUG
    The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.

Study Details

The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.

Key Dates

Start date
Aug 31, 2011
Status verified
Apr 2014
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

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

Arms

  • Experimental: Canagliflozin 100mg
    Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
  • Experimental: Canagliflozin 300mg
    Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
  • Placebo Comparator: Placebo
    Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.

Primary Outcome Measure

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ]

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