Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
This trial is active, not recruiting.
|Sponsor||Profil Institut für Stoffwechselforschung GmbH|
|Start date||February 2015|
|End date||October 2016|
|Trial size||72 participants|
|Trial identifier||NCT02231658, GI-Motil|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.
The highest injected once daily dose will be 20µg s.c. for lixisenatide.
Change from baseline (week -1) in the number of reflux episodes
time frame: 24 hours after 10 weeks of treatment
Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus
time frame: After 10 weeks of treatment
Male or female participants from 18 years up to 65 years old.
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%
|Official title||Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion|
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