Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Lixisenatide.

Glucocorticoids are commonly used in the treatment of autoimmune, inflammatory, and neoplastic diseases.

It had two arms (groups): Patients with Steroid-Induced Diabetes (experimental) and Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia (experimental).

Patients diagnosed with Steroid-induced diabetes, that require insulin therapy.

Patients with history of type 2 diabetes, that developed Steroid-induced hyperglycaemia and require insulin therapy.

The registry classes the interventions as drug.

More on the Plan

Current clinical guidelines classify SID as a form of drug-induced diabetes, with insulin therapy as the primary treatment.

To assess baseline metabolic control, blood samples will be taken.

All study participants will be equipped with a CGM sensor integrated with the hospital clinic system, allowing the study team access to the patients' glycemic data.

Participants assigned to Group 1 will receive standard insulin therapy.

Who Took Part

The registry lists 100 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: Adults (≥18 years of age). Patients with type 2 diabetes and SIH, or diagnosed with SID requiring insulin. Patients undergoing long-term oral GC therapy for the following indications:.

The full record lists 14 inclusion and 6 exclusion criteria; among the exclusions: \- age \<18 years; type 1 diabetes; history of acute pancreatitis or gallstone disease.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

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

It started in 2025-07-10 with completion listed for 2028-02-09.

It ran at 1 site in Poland.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Glucose monitoring index and Time in range (time frame: From enrollment to 6 months).

It also tracked 4 secondary outcomes, for example Assessment of body mass index (BMI), Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire and Number of patients that refused to initiate therapy or discontinued therapy due to personal and/or financial reasons.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Lixisenatide in 100 people.

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

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