Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)

Plain-language guide to NCT03087032: phase 4 randomized trial of Insulin Glargine and Liraglutide, 164 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03087032
Phase: phase 4
Status: recruiting participants
Start: 2019-01-10
Completion (planned or actual): 2025-01-15
Participants: 164 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Patients; Overweight and Obesity; Hyperglycaemia (Diabetic)
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Liraglutide.

It had two arms (groups): Liraglutide-bolus (experimental) and Basal-bolus (active comparator).

The registry classes the interventions as drug.

More on the Plan

Injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs), such as liraglutide, are a relatively new addition to their treatment armamentarium.

Who Took Part

The registry lists 164 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age: 18 - 75 years old. BMI must be greater than 24 and less than 45 kg/m2. Patients with type 2 diabetes who met the World Health Organization (who) diagnostic criteria (1999). Signed informed consent.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: history of pancreatic disease,; history of medullary thyroid carcinoma; lipase level \> 3 times above normal,.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2019-01-10 with completion listed for 2025-01-15.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example the proportion of patients with hypoglycemia, changes in HbA1c, changes from baseline in FPG(mmol/L), changes in body weight ( kilograms), changes in visceral as assessed by dual x-ray absorptiometry (DXA) and number of participants with abnormal laboratory values and/or adverse events that are related to treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Liraglutide in 164 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Liraglutide compound page, all human trials.

Our Notes on the Compounds

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

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.