This trial is active, not recruiting.

Condition diabetes mellitus
Treatments liraglutide, lixisenatide
Phase phase 1
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

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
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.

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 Criteria

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%

Additional Information

Official title Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Profil Institut für Stoffwechselforschung GmbH.