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Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

Plain-language guide to NCT04829903: not phased randomized trial of Liraglutide and Dulaglutide, 116 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04829903
Phase
not phased
Status
completed
Start
2020-01-02
Completion (planned or actual)
2021-03-29
Participants
116 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Type 2 Diabetes Treated With Insulin; Obesity; Adolescent Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Liraglutide and Dulaglutide.

It had two arms (groups): Group DUL (active comparator) and Group LIR (placebo comparator).

Group taking Dulaglutide injections.

Group taking Liraglutide injections.

The registry classes the interventions as drug.

Who Took Part

116 actual participants took part.

It was open to people of any sex aged from 12 years up to 19 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 Diabetes Mellitus. Male or female.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: non obese; not taking metformin; taking other injectable diabetic medications.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2020-01-02 with completion listed for 2021-03-29.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycemic level (time frame: 24 weeks for the duration of the study). BMI (time frame: 24 weeks for the duration of the study). Adverse effects (time frame: 24 weeks for the duration of the study).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide and Dulaglutide in 116 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 and the Dulaglutide 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.

Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.

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.