A Phase 4 interventional study of lixisenatide + glargine and Intensive insulin therapy in Steroid-Induced Diabetes, Steroid-Induced Hyperglycemia and Diabetes, sponsored by Medical University of Warsaw. Enrolling by invitation at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Prevention
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Patients diagnosed with Steroid-induced diabetes, that require insulin therapy
Drug: lixisenatide + glargine · Drug: Intensive insulin therapy
Patients with history of type 2 diabetes, that developed Steroid-induced hyperglycaemia and require insulin therapy
Drug: lixisenatide + glargine · Drug: Intensive insulin therapy
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
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.
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)
Time frame: From enrollment to 6 months
Need for prandial insulin in Group 2 (glucose >200 mg/dL in ≥2 measurements over 2 days)
Time frame: From enrollment to 6 months
Assessment of body mass index (BMI)
weight and height will be combined to report BMI in kg/m\^2
Time frame: Measurements will be taken at the time of enrollment and again after 6 months
Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire
Treatment Satisfaction is rated between 0 and +18, the higher the score the greater the satisfaction with treatment.
Time frame: From enrollment to 6 months
Number of patients that refused to initiate therapy or discontinued therapy due to personal and/or financial reasons
The number of patients that refused to initiate or continue therapy will be measured based on patient's declaration and monthly evaluation.
Time frame: From enrollment to 6 months
Plan to share: No
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Medical University of Warsaw