CANTABILE study

JRCT ID: jRCTs051180112

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: T2DM patients with basic metabolic risks
• Date of first enrollment: 19/02/2018
• Target sample size: 200
• Study type: Interventional

Intervention(s)

Group A: Teneligliptin group: Orally given one tablet of TENELIA 20mg daily from the next day of the 0 week clinic visit until the 24 week of treatment. If the doctor in charge finds it suitable during the treatment with 20mg, dose escalation up to 40mg (2 tablets) once daily is allowed.
Group B: Canagliflozin group: Orally given one tablet of CANAGLU 100mg daily either before or after breakfast from the next day of the 0 week clinic visit until the 24 week of treatment.

Outcome(s)

• Primary Outcome: Rate of subjects who meet one or more of the below criteria : Composite endpoints (a) BMI 25 kg/m2 or more at 0 week of treatment and show 3% or more weight loss at 24 week of treatment. (b) Systolic blood pressure of 130 mmHg or more or diastolic blood pressure of 85 mmHg or more at 0 week and show systolic blood pressure of less than 130 mmHg and diastolic blood pressure of less than 85 mmHg at 24 week of treatment. (c) Fasting triglyceride of 150 mg/dL or more or HDL-C of less than 40 mg/dL at 0 week and fasting triglycreride of less than 150 mg/dL and HDL-C of 40 mg/dL or more at 24 week of treatment.

Secondary Outcome

1) Proportion of study subjects to whom each of the primary endpoints ((a), (b), and (c)) apply
2) Amount of change in HbA1c
3) Amount of change in fasting blood glucose
4) Achievement rate of HbA1c below 6.0% and achievement rate of HbA1c below 7.0%
5) Achievement rate of a decrease of 3% or greater in body weight, achievement rate of a decrease of 5% or greater in body weight (of the study subjects for whom BMI was at 25 kg/m2 or above at treatment period week 0, proportions who had lost at least 3% or at least 5% of body weight at treatment period week 24)
6) Amount of change in abdominal circumference, BMI, and body weight
7) Amount of change in HDL-C and fasting TG
8) Amount of change in blood pressure (systolic blood pressure, diastolic blood pressure)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1. Written informed consent by the patient
2. 20 years old or older, less than 85 years old
3. HbA1c of 7.0% or higher and less than 10.0%
4. Fulfill one or more of the following criteria on the date of consent;
- BMI 25 kg/m2 or higher
- Systolic blood pressure of 130 mmHg or higer, or diastolic blood pressure of 85 mmHg or higher
-Fasting triglyceride of 150 mg/dL or higher, or HDL-C of less than 40 mg/dL
5. No anti-diabetic medication during the preceding 8 weeks, or have been receiving fixed dose metformin hydrochloride monotherapy during the preceding 8 weeks
6. Undertaking dietary and exercise therapy of the same intensity/content during the preceding 8 weeks. Exercise is not mandatory If exercise is not recommended due to complications.

Exclude criteria

1. Type 1 diabetes mellitus
2. BMI of 22 kg/m2 or less
3. Hypersensitivity to contents of TENELIA or CANAGLU
4. Require insulin therapy (Severe ketosis, diabetic coma or precoma, severe infection, perioperative, severe trauma etc.)
5. Congestive heart failure of NYHA III or IV
6. Pregnancy, possible pregnancy, or lactating
7. Malignancy or suspected malignancy
8. Taking unallowed medications or undertaking unallowed therapy defined in the study protocol during the preceding 8 weeks
9. Changes in dosage of concomitantly administered drugs or therapy contents during the preceding 8 weeks
10. Other subjects deemed unsuitable by the doctor in charge of the research

Related Information

• Primary Sponsor: Hosoda Kiminori
• Secondary Sponsor: Mitsubishi Tanabe Pharma Corporation,Mitsubishi Tanabe Pharma Corporation,Mitsubishi Tanabe Pharma Corporation
• Secondary ID(s): UMIN000030343