Effects of once-daily administered GLP-1 Receptoragonist Lixisenatide in combination with basal Insulin on glycemic control in patients with type-2 diabetes mellitus not achieving therapeutic targets with premixed insulin strategy
- Conditions
- 10 patients (both gender) under treatment with premixed insulin (2-3 injections) and HbA1c>7% will be switched to basal insulin glargine (Lantus, once daily) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily).Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-005334-37-AT
- Lead Sponsor
- Medical University of Vienna / Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Age 18 – 80a
•Subjects understand study related activities and give written informed concent
•HbA1c > 7% under treatment with premixed insulin (2-3 injections)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
•Females of child-beering age
•Impaired liver function (transaminase >2x than normal)
•Impaired kidney funciton (creatinin > 1,5 mg/dl)
•Known intolerance against GLP-1 receptor agonists
•History of pancreatitis or pancreas tumor
•Malignancies, autoimmune diseases
•Severe dyslipidemia (serum triglycerides > 400 mg/dl, cholesterol > 300 mg/dl)
•Psychiatric disorder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method