Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial
Not Applicable
- Conditions
- Type 1 and Type 2 Diabetes
- Registration Number
- JPRN-UMIN000021046
- Lead Sponsor
- Showa University School of Medicine Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with a history of hypersensitivity to insulin 2.Patients with severe ketosis, diabetic coma or the former comatose 3.Patients with severe renal dysfunction including the patients needing haemodialysis or peritoneal dialysis 4.Patients with the pre or proliferative retinopathy,including in the vitreous haemorrhage risk. 5.Patients with the serious infection, the perioperative period and the serious trauma 6.Patients with the pregnant woman or the woman who may be pregnant 7.In addition, the patient who judged inappropriate by an attendant physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in HbA1c after 16weeks of treatment from baseline
- Secondary Outcome Measures
Name Time Method Hypoglycemic episodes Change in fasting glucose levels 6-points SMBG profiles DTSQs scale score The change in HbA1c after 24weeks of treatment from baseline