Current partner codePEPTIDESDE
NCT07117240·Phase 4·INTERVENTIONAL

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

Status

Enrolling by invitation

Phase

Phase 4

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 detailed 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.

Interventions

Treatment arms and agents.

DRUG

lixisenatide + glargine

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.

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.

Timeline

From registration to results.

  1. First posted

    Aug 12, 2025

  2. Study start

    Jul 10, 2025

  3. Primary completion

    Feb 9, 2028

  4. Study completion

    Jul 10, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Sep 19, 2025

Outcomes

What the study measures.

Primary outcomes

Glucose monitoring index and Time in range

Time frame · From enrollment to 6 months

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)

Secondary outcomes

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)

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

weight and height will be combined to report BMI in kg/m\^2

Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire

Time frame · From enrollment to 6 months

Treatment Satisfaction is rated between 0 and +18, the higher the score the greater the satisfaction with treatment.

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

Time frame · From enrollment to 6 months

The number of patients that refused to initiate or continue therapy will be measured based on patient's declaration and monthly evaluation.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Poland. Showing up to 24 locations stored in the fast local snapshot.

Warsaw Medical University

Warsaw, Warsaw, Poland

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

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