Safety and efficacy of glinide for the treatment of type 2 diabetic patients
Phase 4
Completed
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000003840
- Lead Sponsor
- Keio University School of Medicine Department of Medicine Division of Nephrology, Endocrinology and Metabolism
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with pretreatment with sulfonyl urea within 3 months 2) Patients who need insulin therapy for the treatment of type 2 diabetes 3) Patients with severe liver dysfunction (AST and/or ALT 100IU/l or more) 4) Patients with severe renal dysfunction (Cr 2.5mg/dl or more) or patients under hemodialysis 5) Patients with uncontrolled hypertension (SBP 180mmHg or more, and/or DBP 110mmHg or more) 6) Patients with severe heart disease 7) Patients with onset of cardiovascular disease within 3 months 8) Patients with malignancy 9) Patients with allergy for glinide 10) Patients with pregnancy 11) Patients whom the doctors do not allow to participate the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c
- Secondary Outcome Measures
Name Time Method fasting plasma glucose, C-peptide, insulin, proinsulin, glycoalbumin, 1,5-AG, serum lipid profile, body weight, adverse events, oxidative stress markers, inflammatory markers, daily capillary glucose profile