Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial
- Conditions
- Diabetes mellitus
- Registration Number
- JPRN-UMIN000020037
- Lead Sponsor
- Kanagawa Cardiovascular and Respiratory Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 30
Not provided
1Patients less than 20 years old or 80 years of age or more 2Patients who are pregnant, breastfeeding or may become pregnant 3Type 1 diabetes mellitus patients 4Insulin-dependent diabetes mellitus patients 5Patients with severe infection or severe trauma 6Patients with severe hepatic disease 7Patients with severe renal disease 8Patients with hypopituitarism and/or adrenal insufficiency 9Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis. 10Patients with a history of pancreatitis 11Patients with malnutrition 12Patients taking DPP4-I,SGLT2I,GLP1 receptor agonists except for dulaglutide 13Patients who considered not eligible for the study by the attending doctor due to other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of HbA1c at the 24th week
- Secondary Outcome Measures
Name Time Method Change of date shown below at the 12th and 24th week. HbA1c(at the 12th week),GA,body weight,blood pressure,total cholesterol,triglyceride,LDL-cholesterol,HDL-cholesterol,fasting plasma glucose,c-peptide(at the 24th week),urine albumin(mg/gCr)(at the 24th week),KL-6