Study on dose adjustment of insulin glargine in type 2 diabetic patients treated with basal supported oral therapy
Not Applicable
- Conditions
- type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000014350
- Lead Sponsor
- Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
diabetes other than type 2 diabetes mellitus history of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or other severe cardiac disease within the preceding 12 months severe renal dysfunction (serum creatinine >2.0mg/dl) severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase >=2.5 times the normal upper limit active proliferative diabetic retinopathy or none of ophthalmologic examination in the past 12 months history of hypoglycemia unawareness pregnancy or breast-feeding
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method indicators of glycemic control such as HbA1c and glycoalbumin
- Secondary Outcome Measures
Name Time Method frequency of hypoglycemia, frequency of severe hypoglycemia, mean fasting blood glucose determined with self-monitoring blood glucose, change of insulin glargine dose, change of DTSQ score, change of weight