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A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

Plain-language guide to NCT06340854: phase 3 randomized trial of Insulin Glargine, 412 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06340854
Phase
phase 3
Status
completed
Start
2024-04-19
Completion (planned or actual)
2025-05-08
Participants
412 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Diabetes, Type 2
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day.

The study medicine will be investigated in participants with type 2 diabetes.

Participants will either get insulin icodec or insulin glargine.

It had two arms (groups): Insulin icodec (experimental) and Insulin glargine U100 (active comparator).

Participants will receive Insulin icodec subcutaneously once weekly.

Participants will receive Insulin glargine subcutaneously once daily.

The registry classes the interventions as drug.

Who Took Part

The registry lists 412 actual participants took part.

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: Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening. Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: any episodes of diabetic ketoacidosis within 90 days prior to the day of screening; myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening; chronic heart failure classified as being in new york heart association class iv at screening.

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.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-04-19 with completion listed for 2025-05-08.

It ran at 83 sites in United States (27), India (16), Poland (8), South Africa (8), Bulgaria (6) and Germany (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycated Haemoglobin (HbA1c) (time frame: Week 0, Week 26).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 412 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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

Our Notes on the Compound

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

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.