DRUG
Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Status
Terminated
Phase
Phase 1
Enrollment
109
Locations
2
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Lixisenatide
Timeline
From registration to results.
First posted
Sep 4, 2014
Study start
Jul 16, 2015
Primary completion
Jul 23, 2018
Study completion
Jul 23, 2018
Results posted
Not reported
Registry updated
Oct 17, 2018
Outcomes
What the study measures.
Primary outcomes
Change from baseline (week -1) in the number of reflux episodes
Time frame · 24 hours after 10 weeks of treatment
Secondary outcomes
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- 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%
Study locations
2 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
St. Josef-Hospital, Universitätsklinik
Bochum, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
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Related PeptideStat pages
Put the record in context.
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