Insulin Degludeg / Insulin Aspart BID injection therapy versus GLP-1 analogue Liraglutide and Insulin Deguldec combination therapy in Tochigi
Not Applicable
Recruiting
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000024865
- Lead Sponsor
- Dokkyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who have experienced severe diabeticketosis, diabetic coma, or past history of pre-coma prior to 6 months Patients with severe infections, severe injury or perioperative state. Female patients who have pregnancy or possibilty of pregnancy, or are under lactation Patients who had past history of hypersensitivity or allergic reaction to insulin degludec, aspart or liraglutide Patients with severe liver or renal dysfunction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change from baseline in HbA1c after 26 and 52 weeks of treatment. The achievement rate of HbA1c < 7.0%
- Secondary Outcome Measures
Name Time Method Changes in HbA1c levels (0,12,26,52 weeks) 7 points plasma glucose (Daily profile) (0,12,26,52 weeks) Changes in body weight and BMI (0,12,26,52 weeks) Dosage of insulin and liraglutide (0,12,26,52 weeks) Frequencies of all hypoglycemic episodes Changes in serum C-peptide (0,52 weeks) CD16/TLR4 on blood monocytes (0,52 weeks) Changes in GOT/GPT (0,52 weeks) Change in coefficient of Variation of R-R intervals (0,52 weeks) Changes in urinary albumin excretion (0,52 weeks)