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

NCT07117240 | Enrolling By Invitation Phase 4

• 1 other identifier: KB/113/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Glucocorticoids are commonly used in the treatment of autoimmune, inflammatory, and neoplastic diseases. Despite their therapeutic efficacy, they are associated with significant metabolic side effects. In the proposed research, the aim is to assess the metabolic efficacy and safety of fixed-ratio combination therapy (basal insulin + GLP-1 receptor agonist) compared to standard insulin therapy in patients with SID. In a selected group of patients, a randomised clinical trial would be conducted to assess the potential benefits of GLP-1 receptor agonists in the management of SID.

Conditions

Steroid-Induced Diabetes; Steroid-Induced Hyperglycemia; Diabetes

Keywords

Steroid-induced diabetes; GLP-1 receptor agonist; Diabetes

Outcome Measures

Primary Outcomes (1)

• Glucose monitoring index and Time in range

  Achievement of glycemic targets measured through Continuous Glucose Monitoring Sensor. Glycemic goals were established at: GMI ≤ 7.0% TIR \> 70% (glucose 70-180 mg/dL)

  From enrollment to 6 months

Secondary Outcomes (4)

• Need for prandial insulin in Group 2 (glucose >200 mg/dL in ≥2 measurements over 2 days)

  From enrollment to 6 months

• Assessment of body mass index (BMI)

  Measurements will be taken at the time of enrollment and again after 6 months

• Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire

  From enrollment to 6 months

• Number of patients that refused to initiate therapy or discontinued therapy due to personal and/or financial reasons

  From enrollment to 6 months

Study Arms (2)

Patients with Steroid-Induced Diabetes

EXPERIMENTAL

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

Drug: lixisenatide + glargine; Drug: Intensive insulin therapy

Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia

EXPERIMENTAL

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

Drug: lixisenatide + glargine; Drug: Intensive insulin therapy

Interventions

lixisenatide + glargine DRUG

Participants assigned to Group 1 will receive standard insulin therapy. Those in Group 2 will be treated with a combination of insulin glargine and lixisenatide, with dosages individually adjusted based on current glucose levels. All participants will be trained in insulin administration and dose adjustment based on glucose readings.

Also known as: GLP-1 plus basal insulin

Patients with Steroid-Induced Diabetes; Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia

Intensive insulin therapy DRUG

Participants assigned to Group 1 will receive standard insulin therapy. Those in Group 2 will be treated with a combination of insulin glargine and lixisenatide, with dosages individually adjusted based on current glucose levels. All participants will be trained in insulin administration and dose adjustment based on glucose readings.

Patients with Steroid-Induced Diabetes; Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Nephrotic syndrome
• Asthma
• Rheumatoid arthritis
• Psoriatic arthritis
• Polymyalgia rheumatica
• Synovitis associated with osteoarthritis
• Sarcoidosis
• Tubulointerstitial nephritis
• Atopic dermatitis
• Pemphigus
• Informed consent

You may not qualify if:

• \- Age \<18 years
• Type 1 diabetes
• Critically ill patients in a life-threatening condition requiring intensive care and medical support to sustain vital functions, as defined by an Allgöwer index \>1.0
• eGFR \<30 mL/min
• History of acute pancreatitis or gallstone disease
• Lack of consent

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Warsaw Medical University

Warsaw, Warsaw, 02-097, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

lixisenatide; Insulin Glargine; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones

Study Officials

• Leszek Czupryniak, Prof. Dr. hab.n.med.

  Medical University of Warsaw

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 12, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): February 9, 2028
• Study Completion (Estimated): July 10, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)