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NCT02231658 Clinical Trial

Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

Diabetes Mellitus Clinical Trial

Official title:
Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02231658
Other study ID # GI-Motil
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date July 16, 2015
Est. completion date July 23, 2018

Study information
Verified date October 2018
Source Profil Institut für Stoffwechselforschung GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 109
Est. completion date July 23, 2018
Est. primary completion date July 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liraglutide

• Lixisenatide

Locations
Country Name City State
Germany St. Josef-Hospital, Universitätsklinik Bochum
Germany Profil Institut für Stoffwechselforschung GmbH Neuss

Sponsors (1)
Lead Sponsor Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline (week -1) in the number of reflux episodes 24 hours after 10 weeks of treatment
Secondary Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus After 10 weeks of treatment
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