Diabetes MellitusPhase 1NCT02231658
Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
A Phase 1 study testing Liraglutide and Lixisenatide in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Liraglutide and Lixisenatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesGermany
- Study dates
- 16 Jul 2015to 23 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
St. Josef-Hospital, Universitätsklinik
Bochum, 44791
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
About this study
Official title: Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Liraglutide, Lixisenatide
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
LixisenatideDrug
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | The highest injected once daily dose will be 1.8 mg s.c. for liraglutide. Receives: Drug: Liraglutide |
| Lixisenatide | Experimental | The highest injected once daily dose will be 20µg s.c. for lixisenatide. Receives: Drug: Lixisenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (week -1) in the number of reflux episodes
Measured: 24 hours after 10 weeks of treatment
Secondary outcomes (1)
Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus
Measured: After 10 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study start16 Jul 2015
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
Why it stopped: Too challenging to recruit appropriate participants at an acceptable speed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juris Meier, MD, Principal investigator, St. Josef Hospital Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231658
- Sponsor's protocol ID
- GI-Motil
- Status last verified
- Oct 2018
- First submitted
- 1 Sep 2014
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32647054
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
- ClinicalTrials.gov ID
- NCT02231658
- Acronym / sponsor ID
- GI-Motil
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too challenging to recruit appropriate participants at an acceptable speed.
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideThe highest injected once daily dose will be 1.8 mg s.c. for liraglutide. |
| Lixisenatide | Experimental | Drug: LixisenatideThe highest injected once daily dose will be 20µg s.c. for lixisenatide. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide | Drug | Liraglutide |
| Lixisenatide | Drug | Lixisenatide |
Primary outcome
Change from baseline (week -1) in the number of reflux episodes
Time frame: 24 hours after 10 weeks of treatment
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Too challenging to recruit appropriate participants at an acceptable speed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Derived from this study: PubMed 32647054Quast 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juris Meier, MD principal investigator
St. Josef Hospital Bochum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liraglutide and Lixisenatide in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Too challenging to recruit appropriate participants at an acceptable speed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (week -1) in the number of reflux episodes (time frame: 24 hours after 10 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02231658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.