Study of the efficacy and safety of insulin degludec who treating with basal insulin glargine or insulin detemir in type 1 diabetes with the Basal-Bolus Therapy
- Conditions
- Type 1 diabetes
- Registration Number
- JPRN-UMIN000012358
- Lead Sponsor
- Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Type 2 diabetes mellitus patients (2) Patients with severe liver disease (3) Patients with severe renal disease (4) Patients who had myocardial infarction within 3 months, or obvious heart failure case (5) Patients with severe pancreas disease (6) Patients having a cancer (7) Patients with hemoglobin (Hb) less than 11 g/dL (8) Patients that the number of the platelets is less than 100,000 /mm3 (9) Patients with high diabetic neuropathy (10) Patients having a proliferative retinopathy (11) Patients with a serious infectious disease or a serious injury (12) Patients with bowel disease or ileus factors (13) Chronic enteropathy patients with the digestion and absorption abnormality (14) Excessive common custom drinker (15) A pregnant woman or the woman who may be pregnant (16) Patients who was infected with hepatitis B virus or hepatitis C virus (17) 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 Daily glucose fluctuation (MAGE,SD), incidence of hypoglycemia, change of QOL,change of HbA1c
- Secondary Outcome Measures
Name Time Method