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

JRCT ID: jRCTs051180036

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 08/05/2018
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Canagliflozin arm: Canagliflozin (100 mg/day) and glimepiride (0-4 mg/day, adjusted by the prescribed algorithm), for 24 weeks
Glimepiride arm: Glimepiride (0-4 mg/day, adjusted by the prescribed algorithm), for 24 weeks

Outcome(s)

• Primary Outcome: Change in disposition index, calculated using blood glucose and insulin values, from baseline to at 1-week after the end of the treatment

Secondary Outcome

Changes in
(1) DI-related outcomes
(2) DI using C-peptide
(3) HbA1c, fasting glucose, fasting insulin
(4) Body weight
(5) CGM glucose levels
(6) HOMA2-%B, iHOMA2 (-%B, -%S)
(7) HOMA2-%S
(8) Dose of glimepiride

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Matsuoka Taka-aki
• Secondary Sponsor: Mitsubishi Tanabe Pharma Corporation
• Secondary ID(s): UMIN000030208