Study Stopped
Too challenging to recruit appropriate participants at an acceptable speed.
Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
1 other identifier
interventional
109
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus
Started Jul 2015
Longer than P75 for phase_1 diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 4, 2014
CompletedStudy Start
First participant enrolled
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2018
CompletedOctober 17, 2018
October 1, 2018
3 years
September 1, 2014
October 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline (week -1) in the number of reflux episodes
24 hours after 10 weeks of treatment
Secondary Outcomes (1)
Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus
After 10 weeks of treatment
Study Arms (2)
Liraglutide
EXPERIMENTALThe highest injected once daily dose will be 1.8 mg s.c. for liraglutide.
Lixisenatide
EXPERIMENTALThe highest injected once daily dose will be 20µg s.c. for lixisenatide.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St. Josef-Hospital, Universitätsklinik
Bochum, 44791, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
Related Publications (1)
Quast DR, Schenker N, Menge BA, Nauck MA, Kapitza C, Meier JJ. Effects of Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists) on Esophageal and Gastric Function in Patients With Type 2 Diabetes. Diabetes Care. 2020 Sep;43(9):2137-2145. doi: 10.2337/dc20-0720. Epub 2020 Jul 9.
PMID: 32647054DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juris Meier, MD
St. Josef Hospital Bochum
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2014
First Posted
September 4, 2014
Study Start
July 16, 2015
Primary Completion
July 23, 2018
Study Completion
July 23, 2018
Last Updated
October 17, 2018
Record last verified: 2018-10