Randomized crossover multi-facility joint comparative test to evaluate the effect on type 1 diabetic patient's blood glucose fluctuation due to difference in long-acting insulin (Insulin Degludec vs Insulin Glargine U300)
Not Applicable
- Conditions
- Type 1 diabetes mellitus
- Registration Number
- JPRN-UMIN000029630
- Lead Sponsor
- Division of Diabetes and Endocrinology Department of Internal Medicine,Kobe University Graduate School of Medicine
- Brief Summary
Comparing the SD of FBG level, IDeg was noninferior to IGla-300 in SD of FBG.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
Not provided
Exclusion Criteria
1)HbA1c > 9.0% 2)other medication to affect glucose concentarion 3)severe hypertension(Systolic blood pressure of 180 mmHg or more, diastolic blood pressure of 100 mmHg or more) 4)severe liver dysfunction (Increase of AST, ALT more than 2.5 times normal upper limit) 5)severe renal dysfunction (Cr > 2) 6)severe heart failure (NYHA>2) 7)Recent serious hypoglycemia, recent hospitalization due to ketoacidosis 8)retinopathy with high bleeding risk 9)pregnant or breast-feeding women 10)Cancer patient 11)psychological disorder 12) others inappropriate for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standard deviation of fasting blood glucose by SMBG
- Secondary Outcome Measures
Name Time Method octurnal blood glucose fluctuation index by flash glucose monitoring