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).
Conditions
Interventions
Trade Name: Lyxumia
Product Name: Lyxumia
Product Code: EMEA/H/C/002445
Pharmaceutical Form: Injection
INN or Proposed INN: lixisenatide
CAS Number: 320367-13-3
Current Sponsor code: EMEA/H/C/002445
O
Sponsors
Medical University of Vienna / Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Introduction of basal insulin therapy in combination with the GLP-1 receptor agonist Lixisenatide in patients with type-2 diabetes previously treated with premixed insulin not achieving therapeutic target will be associated with positive effects on glycemic control: - Changes in HbA1c from baseline to end ;Secondary Objective: -Change in fasting blood glucose -Responder rate (%): HbA1c-reduction =0.4% -Responder rate (%) on HbA1c goal < 7,0% -Change in body weight from baseline to end -Composite responder score: HbA1c-reduction =0.4%-no weight gain- no hypoglycemia -Dosage of insulin -Hypoglycemia (all symptomatic, symptomatic confirmed, all nocturnal, severe and severe nocturnal) -Gastrointestinal side effects (%; treatment termination %) -Other safety endpoints (Adverse Events) ;Primary end point(s): Changes in HbA1c from baseline to end 12 weeks after initiation of altered therapy regiment;Timepoint(s) of evaluation of this end point: monthly (0, 4, 8, 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change in fasting blood glucose -Responder rate (%): HbA1c-reduction =0.4% -Responder rate (%) on HbA1c goal < 7,0% -Change in body weight from baseline to end -Composite responder score: HbA1c-reduction =0.4%-no weight gain- no hypoglycemia -Dosage of insulin -Hypoglycemia (all symptomatic, symptomatic confirmed, all nocturnal, severe and severe nocturnal) -Gastrointestinal side effects (%; treatment termination %) -Other safety endpoints (Adverse Events) ;Timepoint(s) of evaluation of this end point: monthly (0, 4, 8, 12 weeks) | — |
Countries
Austria
Contacts
Public ContactMedical University of Vienna
Medical University of Vienna
Outcome results
None listed