NCT03267576

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

Canagliflozin Continuous Glucose Monitoring (CANA CGM) Trial: A Pilot Randomized, Double-Blind, Controlled, Crossover Study on the Effects of the SGLT-2 Inhibitor Canagliflozin (vs. the DPP-4 Inhibitor Sitagliptin) on Glucose Variability in Mexican Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 19 Years – 54 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

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

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-08-30
• Last updated: 2019-11-29
• Results posted: 2019-11-29

Locations

5 sites across 1 country: Mexico

Regulatory

• FDA-regulated drug study