Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia
Not Applicable
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000012459
- Lead Sponsor
- The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism),Tokyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who take long-acting insulin twice daily 2)Patients in contraindication of degludec 3)Patients who were considered not to be appropriate for administration of degludec by their doctors. 4)Patients who take high dosage of sulfonylurea drug: 3mg or more Glimepiride a day, 5mg or more Glibenclamide a day, 80mg or more Gliclazide a day. 5)Patients who take GLP-1 receptor agonist in combination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of HbA1c levels after 12 weeks from baseline, achievement rate of HbA1c <7.0% and frequency of hypoglycemia in observation period.
- Secondary Outcome Measures
Name Time Method 1)Frequency of blood glucose level is 70mg/dL or lower at self-monitoring of blood glucose (SMBG) conducted 6 times a day within 2 weeks of switching 2)Standard deviation (SD) of blood glucose and intraindividual variability (CV%) at SMBG before breakfast 3)Change of glycoalbumin (GA) level and 1.5AG level in 24 weeks from baseline 4)Study of background factors in cases of attainment and non-attainment of HbA1c <7.0% 5)Change of insulin dosage 6)Changes of DTSQs, DTSQc 7)Changes of weight, BMI