Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents
Not Applicable
Recruiting
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000019096
- Lead Sponsor
- Haga Diabetes Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Not provided
Exclusion Criteria
Type 1 diabetes mellitus patients. Patients with a history of severe ketosis or diabetic coma in previous 6 months. Patients with severe infection, before/after surgery or with severe traumatic injury. Patients to have a plan to be pregnant. Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis. Patients with a history of pancreatitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of HbA1c,body weight at the 52th and the 104th week. As for patients with renal disturbance, change of serum creatinine, urine albumin(mg/gCr), urine protein (g/gCr) at the 52th and the 104th week. As for patients over 70 years old, change of MMSE at the 52th and the 104th week.
- Secondary Outcome Measures
Name Time Method Change of data shown below at the 52th and the 104th week. AST, ALT, gamma-GTP, LDL-C, HDL-C,TG, non-HOL-C, serum creatinine, serum UA, eGFR, 1,5-AG, self-monitoring blood glucose, Urine albumin(mg/gCr),Urine protein (g/gCr)