← Human Trials & Peer-Reviewed Studies
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
Plain-language guide to NCT01973231: phase 4 randomized trial of Liraglutide and Lixisenatide, 404 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01973231
- Phase
- phase 4
- Status
- completed
- Start
- 2013-10
- Completion (planned or actual)
- 2014-11
- Participants
- 404 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Liraglutide and Lixisenatide.
This trial is conducted in Europe.
The registry classes the interventions as drug.
Who Took Part
The registry lists 404 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.
Examples of who could 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. Body Mass Index (BMI) equal to or above 20 kg/m\^2.
The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: history of chronic pancreatitis or idiopathic acute pancreatitis; screening calcitonin value equal to or above 50 ng/l; personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2).
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Liraglutide group and the comparison group ran side by side rather than switching.
Being open-label, the Liraglutide study did not mask who received what.
It started in 2013-10 with completion listed for 2014-11.
It ran at 61 sites in United Kingdom (12), Germany (9), Hungary (8), France (7), Czechia (5) and Finland (5).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) From Baseline (time frame: Week 0, week 26).
It also tracked 6 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) From Baseline, Change in Body Weight From Baseline and Number of Treatment Emergent Adverse Events (TEAEs).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide and Lixisenatide in 404 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Liraglutide compound page and the Lixisenatide compound page, all human trials.
Our Notes on the Compounds
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.