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

Phase 1TerminatedNCT02231658

Profil Institut für Stoffwechselforschung GmbH109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

109

Conditions

Diabetes Mellitus

Interventions

LiraglutideDRUG

LixisenatideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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%

Locations (2)

St. Josef-Hospital, Universitätsklinik

Bochum, Germany

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Outcomes

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

Data from ClinicalTrials.gov

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