Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 Units/mL and insulin glulisine (Basal plus therapy).
Not Applicable
- Conditions
- diabetes
- Registration Number
- JPRN-UMIN000030648
- Lead Sponsor
- Minami Osaka hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1.Serious ketosis, history of diabetic coma or precoma 2.Pregnancy or lactation and patients scheduled 3.Serious infection, trauma, undergo surgery 4.Receiving steroid therapy. 5.Severe liver dysfunction 6.Type 1 diabetes 7.Hypersensitivity to degludec/aspart, glargin, glulisine. 8.History of malignancy or malignancy. 9.Judged to be unsuitable for participation for medical reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of time with in the predefined FGM glucose range of 70-179mg/dl(normal range).
- Secondary Outcome Measures
Name Time Method Percentage of time with in the predefined FGM glucose range of >180mg/dl (hyperglycemia range) <70mg/dl(hypoglycemia range) <54mg/dl(severe hypoglycemia range) Nocturnal hypoglycemia(0:00-5:59) mean glucose level,SD-value,CV-value,Mean Amplitude of Glycemic Excursions,M-value,MODD