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

Medical University of Warsaw

Status and phase: Invitation-only; Phase 4

Conditions: Diabetes; Steroid-Induced Diabetes; Steroid-Induced Hyperglycemia

Treatments: Drug: Intensive insulin therapy; Drug: lixisenatide + glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT07117240

KB/113/2025

Details and patient eligibility

About

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.

Full description

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. Their strongly diabetogenic effect results from the enhanced activity of hyperglycemic hormones, increased insulin resistance, and impaired function of pancreatic β-cells. Current clinical guidelines classify SID as a form of drug-induced diabetes, with insulin therapy as the primary treatment. However, recent studies highlight the role of glucocorticoids in exacerbating insulin resistance, inhibiting incretin effects, and promoting weight gain-factors that suggest a potential therapeutic role for GLP-1 receptor agonists. It is estimated that approximately 100 patients will be needed to achieve statistically significant results. Participants will be stratified based on the type of diabetes (type 2 diabetes vs. steroid-induced diabetes), followed by alternate randomisation into one of two therapeutic groups:

Group 1: Patients receiving insulin therapy Group 2: Patients receiving an FRC therapy (insulin glargine and lixisenatide) A clinical research team will perform body composition analysis using bioelectrical impedance analysis (BIA) with a Tanita scale. 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. 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. After hospital discharge, patients will continue to be monitored by the study team using data from the CGM system. The researcher will frequently assess the Glucose Management Indicator (GMI), Time in Range (TIR), daily insulin requirements, and frequency of hypoglycemic episodes.

Follow-up phone calls will be attempted every 2 months. If two consecutive contact attempts are unsuccessful, the study will continue based solely on CGM data. A final follow-up visit will take place after 6 months. During this visit, body composition will be reassessed, and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) will be administered to evaluate patient-reported quality of life.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• - 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patients with Steroid-Induced Diabetes

Experimental group

Description:

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

Treatment:

Drug: lixisenatide + glargine

Drug: Intensive insulin therapy

Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia

Experimental group

Description:

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

Treatment:

Drug: lixisenatide + glargine

Drug: Intensive insulin therapy