Table of Contents
- Overview of the trials
- Who the trials include
- What the trials are measuring
- Trial phases and study design
- Key studies that mention Insulin Glargine
- Patient-friendly explanation of key terms
Overview of the trials
The trial data show that Insulin Glargine is being used as a comparison treatment in several Phase 3 studies for diabetes.[1][2] These studies mainly look at how well blood sugar is controlled and how Insulin Glargine compares with newer insulin options or other diabetes medicines.[1][3]
Some studies focus on people with type 1 diabetes, while others focus on type 2 diabetes, including people with overweight, obesity, or increased cardiovascular risk.[2][3] One study also looks at the trial process itself, such as recruitment, retention, and data quality, in people treated with Toujeo.[6]
Who the trials include
Most of the trials include adults with type 2 diabetes.[1][3][4][5] One trial includes adults with type 1 diabetes and compares once-weekly insulin icodec with once-daily Insulin Glargine, both used with insulin aspart.[2]
Some studies are designed for people with extra health risks, such as overweight, obesity, or increased cardiovascular risk.[3][4] One study also separates patients with type 2 diabetes into groups based on whether they have more insulin resistance or more insulin secretion deficit, to see whether treatment response differs.[9]
What the trials are measuring
The most common primary endpoint is change in HbA1c, which shows average blood sugar over the past 2 to 3 months.[1][2][4][5][7][8]
Some trials look at whether a treatment is non-inferior, which means it should not be worse than the comparison treatment by more than a set limit.[1][2][4][7][8] Other outcomes include time to a first major adverse cardiovascular event, body weight, study completion, diversity of participants, adherence to daily injections, and data quality.[3][6]
In one trial, the endpoint is not only blood sugar control but also heart-related outcomes, including MACE-4, which means heart attack, stroke, hospital stay for unstable angina, or cardiovascular death.[3] Another study measures heart rhythm-related markers and progression of cardiovascular autonomic neuropathy, which means nerve damage that can affect heart control.[7]
Trial phases and study design
All the listed studies are Phase 3 trials.[1][2][3][4][5][6][7][8][9] Phase 3 studies are larger studies that compare treatments in people and help confirm whether the results hold up in a broader group.[1][2]
Most of the studies are interventional, which means researchers assign a treatment and then measure the results.[1][2][3][4][5][6][7][8][9] Several studies compare Insulin Glargine with once-weekly insulin icodec, semaglutide-based combinations, or other diabetes treatments.[1][2][4][5][8]
Key studies that mention Insulin Glargine
2024-519945-31-00 is a 26-week Phase 3 study in adults with type 1 diabetes.[2] It compares once-weekly insulin icodec with once-daily Insulin Glargine, both combined with insulin aspart, and the main endpoint is change in HbA1c after 26 weeks.[2]
2022-502833-25-00 is a large Phase 3 study in people with type 2 diabetes and obesity or overweight at increased cardiovascular risk.[3] It compares oral orforglipron with Insulin Glargine and measures time to the first major adverse cardiovascular event.[3]
2024-510612-75-00 studies adults with type 2 diabetes and overweight.[4] It compares semaglutide plus a lower dose of Insulin Glargine with a higher dose of Insulin Glargine alone, and the main endpoint is change in HbA1c after 40 weeks.[4]
2022-502679-43-00 looks at people with type 2 diabetes treated with once-daily basal insulin with or without metformin.[5] The study compares CagriSema with placebo and measures change in HbA1c after 40 weeks, while Insulin Glargine is one of the basal insulin options listed in the study treatments.[5]
2022-500449-26-00 is a Phase 3 study in people with type 2 diabetes mellitus treated with Toujeo.[6] It does not mainly test blood sugar change; instead, it studies whether decentralised and hybrid trial methods can improve recruitment, retention, diversity, adherence, and data quality.[6]
2025-521748-39-00 is an authorised Phase 3 study in type 2 diabetes that includes Insulin Glargine as one of several treatments.[7] It looks at heart-related nerve function and glucose variability over 6 months.[7]
2023-506084-34-00 compares once-weekly insulin icodec with daily Insulin Glargine in adults with type 2 diabetes.[8] The main endpoint is change in HbA1c after 26 weeks, with a non-inferiority goal.[8]
2022-502484-38-00 compares IcoSema with daily Insulin Glargine in people with type 2 diabetes not well controlled on oral medicines.[8] The primary outcome is change in HbA1c after 40 weeks, and the study aims to show superiority of IcoSema over Insulin Glargine.[8]
2024-516542-19-00 is an authorised Phase 3 study in type 2 diabetes that uses Insulin Glargine among other treatments.[9] It explores whether treatment response differs between people with more insulin resistance and those with more insulin secretion deficit, using HbA1c and other biomarkers.[9]
Patient-friendly explanation of key terms
Basal insulin means insulin used to provide background control of blood sugar through the day and night.[1][2][4][5][8]
Insulin aspart is used in one study together with Insulin Glargine or insulin icodec, so the trial can compare two different treatment plans.[2]
Cardiovascular means related to the heart and blood vessels.[3] In one study, this includes events like heart attack, stroke, unstable angina, or cardiovascular death.[3]
Recruitment means how quickly a study can find and enroll participants, while retention means how many stay in the study until the end.[6]
Adherence means how well participants follow the daily injection plan or other study instructions.[6]
Biomarkers are measurable signs in the body, such as HbA1c or other blood markers, that help researchers understand treatment effects.[9]
