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

Sponsor
Profil Institut für Stoffwechselforschung GmbH
Study ID
NCT02231658
Phase
PHASE1
Status
Terminated

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 16, 2015
Status verified
Oct 2018
Primary completion
Jul 23, 2018
Completion
Jul 23, 2018

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    The highest injected once daily dose will be 1.8 mg s.c. for liraglutide.
  • Experimental: Lixisenatide
    The highest injected once daily dose will be 20µg s.c. for lixisenatide.

Primary Outcome Measure

Change from baseline (week -1) in the number of reflux episodes [ Time Frame: 24 hours after 10 weeks of treatment ]

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