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A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
Plain-language guide to NCT01916174: phase 1 randomized trial of Liraglutide, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01916174
- Phase
- phase 1
- Status
- completed
- Start
- 2013-08
- Completion (planned or actual)
- 2013-11
- Participants
- 50 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2; Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Liraglutide.
This trial is conducted in Europe.
The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
It had two arms (groups): Insulin degludec/liraglutide, B5 (experimental) and Insulin degludec/liraglutide, V2 (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 50 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy male and female volunteers. Body mass index (BMI) between 18.5 and 27.0 kg/m\^2 (both inclusive). Body weight between 60 and 90 kg (both inclusive).
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: drug or alcohol abuse.
How the Study Was Run
It was run as a randomized, crossover and double-blind study.
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.
Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.
As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2013-08 with completion listed for 2013-11.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 6 secondary outcomes, for example Time to maximum IDeg concentration.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Liraglutide in 50 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.