An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03267576
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 54 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin 300 mg — DRUG
    Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.
  • Sitagliptin 100 mg — DRUG
    Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.
  • Metformin — DRUG
    Participants will receive metformin at a stable dose of \>= 1500 mg/day throughout the study including the washout period between each intervention.

Study Details

The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.

Key Dates

Start date
Oct 27, 2017
Status verified
Nov 2019
Primary completion
Oct 1, 2018
Completion
Oct 1, 2018

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence AB
    Participants will receive metformin monotherapy at stable doses (greater than or equal to \[\>=\] 1500 milligram per day \[mg/day\]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin \>=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
  • Experimental: Treatment Sequence BA
    Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period.

Primary Outcome Measure

Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1 [ Time Frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) ]

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