Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Age 18 - 70a
- HbA1c between 7 - 10 % under treatment with premixed insulin (2-3 injections)
- Subjects understand study related activities and give written informed concent
- Age 18 - 70a
- HbA1c between 7 - 10 % under treatment with premixed insulin (2-3 injections)
- Subjects understand study related activities and give written informed concent
Exclusion Criteria
- Oral glucose lowering medication except for metformin
- Impaired liver function (transaminase >2x than normal)
- Known intolerance against GLP-1 receptor agonists
- ...
- Oral glucose lowering medication except for metformin
- Impaired liver function (transaminase >2x than normal)
- Known intolerance against GLP-1 receptor agonists
- Impaired kidney function (creatinin > 1,2 mg/dl)
- Severe dyslipidemia (serum triglycerides > 400 mg/dl, cholesterol > 300 mg/dl)
- Psychiatric disorder
- Malignancies, autoimmune diseases
- Females of child-bearing age
- Gastrointestinal disease associated with prolonged nausea and vomiting
- History of pancreatitis or pancreas tumor
- History of hypoglycemia unawareness
Summary
- Conditions
- Type 2 Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Inclusion Criteria
- Age 18 - 70a
- HbA1c between 7 - 10 % under treatment with premixed insulin (2-3 injections)
- Subjects understand study related activities and give written informed concent
- Age 18 - 70a
- HbA1c between 7 - 10 % under treatment with premixed insulin (2-3 injections)
- Subjects understand study related activities and give written informed concent
Exclusion Criteria
- Oral glucose lowering medication except for metformin
- Impaired liver function (transaminase >2x than normal)
- Known intolerance against GLP-1 receptor agonists
- ...
- Oral glucose lowering medication except for metformin
- Impaired liver function (transaminase >2x than normal)
- Known intolerance against GLP-1 receptor agonists
- Impaired kidney function (creatinin > 1,2 mg/dl)
- Severe dyslipidemia (serum triglycerides > 400 mg/dl, cholesterol > 300 mg/dl)
- Psychiatric disorder
- Malignancies, autoimmune diseases
- Females of child-bearing age
- Gastrointestinal disease associated with prolonged nausea and vomiting
- History of pancreatitis or pancreas tumor
- History of hypoglycemia unawareness
Tracking Information
- NCT #
- NCT02168491
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michael Krebs, MD, Prof. Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria
- Michael Krebs, MD, Prof. Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria
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