iraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection in patients with well controlled type 2 diabetes : a randomized controlled trial
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000007009
- Lead Sponsor
- Yokohama City Unuversity Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry. 2. Patients with during pregnancy or lactation. 3. severe infection, before operation, severe trauma 4. Patients who received steroid therapy 5. Patients with history of cardiac failure. 6. Patients with renal insufficiency (serum creatinine > 1.5mg/dl (male) , > 1.3mg/dl (female), e-GFR < 50ml/min). 7. Patients with severe liver dysfunction. 8. Patients with type1 diabetes. 9. Patients with disorder of insulin secretion (serum C-peptide < 0.5ng/ml) 10. Patients who are hypersensitive to these medicines 11. Patients judged to be inappropriate by physicians in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir.
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose and self-monitoring blood glucose and body weight at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir , Diabetes treatment satisfaction questionnaire (DTSQ) , Frequency of side effects (digestive symptoms, hypoglycemia)