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DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
Plain-language guide to NCT01575301: not phased interventional trial of Exenatide and Liraglutide, 411 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01575301
- Phase
- not phased
- Status
- completed
- Start
- 2011-03
- Completion (planned or actual)
- 2015-07
- Participants
- 411 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Exenatide and Liraglutide.
The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.
The registry classes the interventions as drug.
More on the Plan
To develop a cohort of patients treated with GLP-1 R Agonists who are phenotyped at baseline and at 6 month follow up to determine clinical, imaging and other biomarker predictors of glycaemic response to GLP-1R Agonists.
This is a cohort study of 800 patients being treated with either exenatide or liraglutide for 6 months, and carried out in 4 UK centres.
Who Took Part
411 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist. On any combination of oral hypoglycaemic agents. On Insulin (+/- oral hypoglycaemic agents). Age ≥ 18 and \< 80.
The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: type 1 diabetes; pregnancy or lactation; inability to consent.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Exenatide 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 2011-03 with completion listed for 2015-07.
It ran at 4 sites in United Kingdom (4).
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Change in HbA1c between baseline and 6 months (time frame: 6 months).
What This Means in Plain Language
Put simply, this is a not phased trial of Exenatide and Liraglutide in 411 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page and the Liraglutide compound page, all human trials.
Our Notes on the Compounds
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
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.