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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)
Plain-language guide to NCT00905255: phase 3 randomized trial of Lixisenatide, 69 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00905255
- Phase
- phase 3
- Status
- completed
- Start
- 2009-05
- Completion (planned or actual)
- 2011-01
- Participants
- 69 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Lixisenatide.
The primary objective of this study is to evaluate the safety of lixisenatide once daily treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a 2-step initiation regimen in patients with type 2 diabetes in Japan.
It had two arms (groups): Lixisenatide (Two-step Titration) (experimental) and Lixisenatide (One-step Titration) (experimental).
The registry classes the interventions as device and drug.
Who Took Part
Enrollment: 69 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Lixisenatide group and the comparison group should start out alike.
The Lixisenatide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Lixisenatide study: the participants and staff both knew the treatment.
It started in 2009-05 with completion listed for 2011-01.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring.
It also tracked 6 secondary outcomes, for example Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76, Change From Baseline in Body Weight for All Patients at Week 52 and 76 and Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Lixisenatide in 69 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Lixisenatide compound page, all human trials.
Our Notes on the Compound
Lixisenatide: A 44-amino-acid once-daily GLP-1 receptor agonist based on exendin-4; sold as Adlyxin/Lyxumia and in Soliqua with insulin glargine.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.