Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Plain-language guide to NCT04893148: phase 4 randomized trial of Insulin Glargine and Dulaglutide, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04893148
Phase: phase 4
Status: status unknown
Start: 2020-05-26
Completion (planned or actual): 2021-12-30
Participants: 40 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Mellitus; Glucose, High Blood
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Dulaglutide.

It had two arms (groups): iGlar/Lixi (active comparator) and Dulaglutide plus insulin glargine (active comparator).

The registry classes the interventions as drug.

More on the Plan

Treatments were compared in terms of glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) change from baseline, and variables from continuous glucose monitoring (CGM) system; in addition to safety issues on hypoglycemia and changes in weight.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥ 18 years old. Patient accepting to participant to this study.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: pregnant or breastfeeding woman; chronic or acute hepatic disorder (hbv or hcv hepatitis, liver cirrhosis etc.) (ast/alt \> 2.5\*uln); prescription such as immunosuppressant agents, glucocorticoids.

How the Study Was Run

Design: 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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2020-05-26 with completion listed for 2021-12-30.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in glycated hemoglobin (HbA1c) (time frame: Baseline, week 12).

It also tracked 6 secondary outcomes, for example Changes in fasting plasma glucose (FPG), Changes in glucose time in range (TIR), Changes in glucose time above range (TAR), Changes in glucose time below range (TBR), Incidence of hypoglycemia and Changes in weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Dulaglutide in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Dulaglutide 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.

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

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.