jRCTs051180112CompletedNot Applicable
Comparison of canagliflozin vs. tenegliptin against basic metabolic risks in patients with type 2 diabetes mellitus (CANTABILE study)
Not provided0 sites200 target enrollmentStarted: February 19, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Primary Endpoint
- Composite endpoint (a)
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 85age old not (—)
- Sex
- All
Inclusion Criteria
- •Written informed consent by the patient
- •20 years old or older, less than 85 years old
- •HbA1c of 7.0% or higher and less than 10.0%
- •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
- •No anti-diabetic medication during the preceding 8 weeks, or have been receiving fixed dose metformin hydrochloride monotherapy during the preceding 8 weeks
- •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.
Exclusion Criteria
- •Type 1 diabetes mellitus
- •BMI of 22 kg/m2 or less
- •Hypersensitivity to contents of TENELIA or CANAGLU
- •Require insulin therapy (Severe ketosis, diabetic coma or precoma, severe infection, perioperative, severe trauma etc.)
- •Congestive heart failure of NYHA III or IV
- •Pregnancy, possible pregnancy, or lactating
- •Malignancy or suspected malignancy
- •Taking unallowed medications or undertaking unallowed therapy defined in the study protocol during the preceding 8 weeks
- •Changes in dosage of concomitantly administered drugs or therapy contents during the preceding 8 weeks
- •Other subjects deemed unsuitable by the doctor in charge of the research
Outcomes
Primary Outcomes
Composite endpoint (a)
Time Frame: 24 week of treatment
BMI 25 kg/m2 or more at 0 week of treatment and show 3% or more weight loss at 24 week of treatment.
Composite endpoint (b)
Time Frame: 24 week of treatment
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.
Composite endpoint (c)
Time Frame: 24 week of treatment
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 Outcomes
- Proportion of study subjects to whom each of the primary endpoints ((a), (b), and (c)) apply
- Amount of change in HbA1c
- Amount of change in fasting blood glucose
- Achievement rate of HbA1c below 6.0% and achievement rate of HbA1c below 7.0%
- Achievement rate of a decrease of 3% or greater in body weight, achievement rate of a decrease of 5% or greater in body weight(treatment period week 24)
- Amount of change in abdominal circumference, BMI, and body weight
- Amount of change in HDL-C and fasting TG
- Amount of change in blood pressure (systolic blood pressure, diastolic blood pressure)
Investigators
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