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

Profil Institut für Stoffwechselforschung

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Liraglutide; Drug: Lixisenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02231658

GI-Motil

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

Liraglutide

Experimental group

Description:

The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.

Treatment:

Drug: Liraglutide

Lixisenatide

Experimental group

Description:

The highest injected once daily dose will be 20µg s.c. for lixisenatide.

Treatment:

Drug: Lixisenatide