Comparative study of sitagliptin, vildagliptin and alogliptin in patients with type 2 diabetes inadequately controlled with metformin and/or sulfonylurea: a randomized, open labeled trial.
Not Applicable
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000007078
- Lead Sponsor
- Yokohama City Unuversity School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with history of diabetic ketoacidosis or diabetic coma within 6 months prior to the study recruitment. 2.Patients with history of cardiac failure. 3.Patients who received surgical operation during the study. 4.Patients with severe infection or severe trauma. 5.Patients during pregnancy or lactation. 6.Patients with renal insufficienc(serum reatinine > 1.5mg/dl, e-GFR < 30ml/min). 7.Patients with severe liver dysfunction. 8.Patients who received insulin therapy. 9.Patients with history of hypersensitive reaction to sitagliptin, vildagliptin or alogliptin. 10.Patients determined to be inappropriate by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FPG and HbA1c at 0, 8, 16 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin.
- Secondary Outcome Measures
Name Time Method TG, LDL-C, HDL-C, body weight, fasting insulin and glucagon at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. AST, ALT,gamma-GTP, fibrinogen and type 4 collagen 7S at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. BUN, Cr, e-GFR, microalbuminuria and cystatin C at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin. Frequency of adverse effects such as hypoglycemia and gastrointestinal symptom after administration of sitagliptin, vildagliptin or alogliptin.