Diabetes Mellitus
Conditions
Brief summary
The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.
Interventions
DRUGLiraglutide
DRUGLixisenatide
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Male or female aged 18-65 years (both inclusive) * T2DM diagnosis
Exclusion criteria
* Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics * Use of GLP-1 mimetics or DPP-IV inhibitors * Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (week -1) in the number of reflux episodes | 24 hours after 10 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus | After 10 weeks of treatment |
Countries
Germany
Outcome results
None listed