Effect of canagliflozin on the disposition index, a marker of pancreatic beta-cell function: a randomized controlled study

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-jRCTs051180036
• Lead Sponsor: Matsuoka Taka-aki

Brief Summary

Adding canagliflozin to patients with Type 2 diabetes mellitus whose glycemic control was inadequate despite stable triple therapy improved blood glucose control and showed numerical improvement of beta-cell function that did not reach significance. This study also demonstrated a correlation between change in DI and blood glucose.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-29
• Study Completion: 2019-02-20
• Results First Posted: 2020-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Type 2 diabetic outpatients giving written informed consent for the study participation
2) Aged 20-75 years at informed consent
3) Not achieving the individual glycemic target, according to Treatment Guide for Diabetes 2016-2017, by Japan Diabetes Society
4) Undergoing unchanged diet and exercise therapy over 12 weeks
5) Treated with a constant dose of teneligliptin (20 mg/day) over 12 weeks
6) Treated with a constant dose of glimepiride (0.5-2 mg/day) over 12 weeks
7) Treated with a constant dose of metformin over 12 weeks (or treated with a constant dose of teneligliptin and glimepiride over 12 weeks, having reasonable reason for not taking metformin)
8) Not taking prohibited concomitant medications over 12 weeks

Exclusion Criteria

(1) Type 1 diabetes mellitus
(2) Need insulin treatment
(3) History of hypersensitivity to canagliflozin
(4) Heart failure (NYHA class IV)
(5) eGFR<45 mL/min/1.73 m2
(6) Severe hepatic dysfunction
(7) Pregnancy, nursing or planning to become pregnant during the study
(8) Suspected or diagnosed malignant tumors
(9) Participating in another interventional study
(10) Considered by a study physician to be inappropriate due to any other reasons listed above

Study & Design

• Study Type: Interventional
• Study Design: Not specified