Efficacy and safety of metformin dose up in Japanese patients with type 2 diabetes inadequately controlled by combination therapy with vildagliptin and low-dose metformi
Not Applicable
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000013108
- Lead Sponsor
- Juntendo university Department of Metabolism and Endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) history of lactic acidosis 2) renal dysfunction 3)under hemodialysis 4)serious liver disease with >100 IU/L in AST and/or ALT 5) Type 1 diabetes 6) under insulin treatment 7) under treatment for cancer 8) proliferative diabetic retinopathy 9)Excess consumption of alcohol 10) gastrointestinal disorders such as diarrhea and vomiting concern to dehydration 11) severe ketosis and diabetic coma or pre-coma 12)serious infective diseases, serious injury, pre- and per-operation 13) during pregnancy and lactation. 14) hypersensitivity of vildagliptin and metformin 15) high dose metformin treatment (>750mg/day)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of HbA1c from baseline
- Secondary Outcome Measures
Name Time Method 1)Target achievement rate of HbA1c (<6.0%) 2)Changes of insulin, glucagon, C-peptide, proinsulin/insulin rate, DPP-4 activity 3)Symptomatic hypoglycemic events and gastrointestinal disorders 4)inflammatory cytokines and lipid levels