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Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin
Plain-language guide to NCT01169779: phase 3 randomized trial of Lixisenatide, 391 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01169779
- Phase
- phase 3
- Status
- completed
- Start
- 2010-07
- Completion (planned or actual)
- 2011-12
- Participants
- 391 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Lixisenatide.
It had two arms (groups): Lixisenatide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as device and drug.
More on the Plan
The study duration for each patient is 27 weeks +/- 10 days (up to 2 weeks screening + 1 week run-in + 24 weeks double-blind treatment + 3 days follow-up).
Who Took Part
Enrollment: 391 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Lixisenatide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Lixisenatide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2010-07 with completion listed for 2011-12.
It ran at 35 sites in China (28), Hong Kong (3), Malaysia (3) and Thailand (1).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline, Week 24).
It also tracked 7 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24, Change From Baseline in Body Weight at Week 24, Change From Baseline in Glucose Excursion at Week 24 and Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Lixisenatide in 391 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.