Recruitment

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

Known intolerance against GLP-1 receptor agonists
Gastrointestinal disease associated with prolonged nausea and vomiting
Impaired kidney function (creatinin > 1,2 mg/dl)
...
Known intolerance against GLP-1 receptor agonists
Gastrointestinal disease associated with prolonged nausea and vomiting
Impaired kidney function (creatinin > 1,2 mg/dl)
History of pancreatitis or pancreas tumor
Severe dyslipidemia (serum triglycerides > 400 mg/dl, cholesterol > 300 mg/dl)
Psychiatric disorder
Impaired liver function (transaminase >2x than normal)
Females of child-bearing age
Oral glucose lowering medication except for metformin
Malignancies, autoimmune diseases
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

Known intolerance against GLP-1 receptor agonists
Gastrointestinal disease associated with prolonged nausea and vomiting
Impaired kidney function (creatinin > 1,2 mg/dl)
...
Known intolerance against GLP-1 receptor agonists
Gastrointestinal disease associated with prolonged nausea and vomiting
Impaired kidney function (creatinin > 1,2 mg/dl)
History of pancreatitis or pancreas tumor
Severe dyslipidemia (serum triglycerides > 400 mg/dl, cholesterol > 300 mg/dl)
Psychiatric disorder
Impaired liver function (transaminase >2x than normal)
Females of child-bearing age
Oral glucose lowering medication except for metformin
Malignancies, autoimmune diseases
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