T2DM patients with basic metabolic risks
Conditions
Interventions
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 duri
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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 concomittantly administered drugs or therapy contents during the preceding 8 weeks 10. Other subjects deemed unsuitable by the doctor in charge of the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMasato Kasahara
Nara Medical University Clinical Research Center
Outcome results
None listed