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Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
Plain-language guide to NCT01960179: phase 3 interventional trial of Lixisenatide, 361 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01960179
- Phase
- phase 3
- Status
- completed
- Start
- 2013-11
- Completion (planned or actual)
- 2015-03
- Participants
- 361 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Lixisenatide.
It had 1 arm (groups): lixisenatide (experimental).
Lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment).
The registry classes the interventions as drug.
More on the Plan
* Group 1: 60 weeks ± 11 days * Group 2: 32 weeks ± 7 days.
Who Took Part
Enrollment: 361 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.
Examples of who could join: Patients with type 2 diabetes mellitus diagnosed for at least 2 months. Signed written informed consent.
The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: at screening; age \<20 years;; use of more than one oad within 3 months prior to screening;.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Lixisenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2013-11 with completion listed for 2015-03.
It ran at 30 sites in Japan (30).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data (time frame: from baseline to 24 weeks and 52 weeks).
It also tracked 3 secondary outcomes, for example Absolute change in HbA1c, Absolute change in fasting plasma glucose and Absolute change in body weight.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Lixisenatide in 361 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.