Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial.
Not Applicable
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000033867
- Lead Sponsor
- Asahikawa Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
Not provided
Exclusion Criteria
1)Contraindications to alogliptin, vildagliptin, and metformin 2)Diabetic patients with type 1 diabetes and other causes 3)Diabetic ketoacidosis 4)Patients with a history of severe hypoglycemia with coma or loss of consciousness 5)Severe infection, severe trauma 6)Patients with poorly controlled hypertension despite drug treatment 7)Severe renal, hepatic and heart disease 8)Proliferative retinopathy 9)Patients with a history of malignant tumors 10)Not suitable for participate in this study from serious complications judged by a doctor 11)Women with the potential to become pregnant or pregnant, and lactating women 12)Patients judged by doctors to be inappropriate for participation in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes of HbA1c levels and fasting plasma glucose levels
- Secondary Outcome Measures
Name Time Method 1) Body weight, Waist circumference, Blood pressure 2) Fasting insulin and glucagon concentrations 3) Homeostasis model assessment-insulin resistance (HOMA-IR), Homeostasis model assessment of beta cell function (HOMA-beta), Serum lipids 4) Blood glucose area and blood glucose fluctuation index by flash glucose monitoring (FGM)