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Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers
Plain-language guide to NCT01507337: phase 1 non-randomized trial of Liraglutide, 32 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01507337
- Phase
- phase 1
- Status
- completed
- Start
- 2004-04
- Completion (planned or actual)
- 2004-06
- Participants
- 32 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Liraglutide.
This trial is conducted in Europe.
The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.
It had two arms (groups): Elderly (experimental) and Young (experimental).
The registry classes the interventions as drug.
Who Took Part
32 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments. Age, young subjects: age 18-45 years (both incl.). Age, elderly subjects: age at least 65 years. Body Mass Index (BMI) 18-30 kg/m\^2 (both incl.). Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg.
The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: impaired renal function; active hepatitis b and/or active hepatitis c; positive hiv (human immunodeficiency virus) antibodies.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
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 2004-04 with completion listed for 2004-06.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Area under the liraglutide plasma concentration time curve (AUC 0-t).
It also tracked 5 secondary outcomes, for example Area under the liraglutide plasma concentration time curve (AUC 0-infinity), Cmax, maximum liraglutide plasma concentration, tmax, time to reach Cmax, t½, terminal plasma elimination half-life and Adverse events.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Liraglutide in 32 people.
Its size is small, so on its own it can only give an early look.
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.