Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes
Not Applicable
- Conditions
- Type 1 diabetes mellitus
- Registration Number
- JPRN-UMIN000010634
- Lead Sponsor
- Kitano Hospital, The Tazuke Kofukai Medical Research Institute
- 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. The patients who did not agree with this study 2. The patients with serious complications 3. The patients who are at high risk for hypoglycemia 4. The patients who have the history of severe hypoglycemia (needed an emergency transport according to the hypoglycemia unawareness) 5. Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in HbA1c at 4, 12 and 24 weeks and insulin dose
- Secondary Outcome Measures
Name Time Method Changes in mean blood glucose level, SD value, MAGE value, rate and duration of hyper/hypoglycemia, glycemic pattern and area under the carve after long-acting insulin injection, (evaluated by SMBG/CGM), body weight, and frequency of hypoglycemia