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

Primary Purpose

Diabetes Mellitus

Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Liraglutide
Lixisenatide
Sponsored by
Profil Institut für Stoffwechselforschung GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

  • St. Josef-Hospital, Universitätsklinik
  • Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Liraglutide

Lixisenatide

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline (week -1) in the number of reflux episodes

Secondary Outcome Measures

Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus

Full Information

First Posted
September 1, 2014
Last Updated
October 15, 2018
Sponsor
Profil Institut für Stoffwechselforschung GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02231658
Brief Title
Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Official Title
Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Too challenging to recruit appropriate participants at an acceptable speed.
Study Start Date
July 16, 2015 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Profil Institut für Stoffwechselforschung GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Description
The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.
Arm Title
Lixisenatide
Arm Type
Experimental
Arm Description
The highest injected once daily dose will be 20µg s.c. for lixisenatide.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Type
Drug
Intervention Name(s)
Lixisenatide
Primary Outcome Measure Information:
Title
Change from baseline (week -1) in the number of reflux episodes
Time Frame
24 hours after 10 weeks of treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juris Meier, MD
Organizational Affiliation
St. Josef Hospital Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Josef-Hospital, Universitätsklinik
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32647054
Citation
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.
Results Reference
derived

Learn more about this trial

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

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