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GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients
Plain-language guide to NCT01592279: phase 4 randomized trial of Liraglutide, 124 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01592279
- Phase
- phase 4
- Status
- status unknown
- Start
- 2012-06
- Completion (planned or actual)
- 2014-06
- Participants
- 124 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Uncontrolled Type 1 Diabetic Patients
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Liraglutide.
The new incretin-based therapies offer appealing advantages over existing drugs.
The glucose lowering effects resulting from the inhibition of glucagon secretion and the gastric emptying rate could be of clinical importance in type 1 diabetes.
It had two arms (groups): liraglutide (experimental) and Insulin injections (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 124 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: HbA1C ≥ 8 at screening and at qualification. Not treated with GLP-1 analogue.
The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: moderate and sever hypoglycemia; creatinin \> 2; amylase or lipase \> 3xuln.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.
The Liraglutide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and investigator.
It started in 2012-06 with completion listed for 2014-06.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Endogenous insulin secretion and residual β-cell function estimated by the value of C-peptide.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 124 people.
Its status is unknown; 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.