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Trial · Interventional

Enrolling by invitationPhase 4Registry data

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

NCTNCT07117240 (opens ClinicalTrials.gov in a new tab)Other idKB/113/2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Enrolling by invitation
Phase
Phase 4
Enrollment
100 participants (estimated)
Sponsor
Medical University of Warsaw · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Poland

Start
10 Jul 2025
Primary completion
9 Feb 2028 (estimated)
Completion
10 Jul 2028 (estimated)
First posted
12 Aug 2025
Last update posted
19 Sept 2025
Conditions
Steroid-Induced Diabetes · Steroid-Induced Hyperglycemia · Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 4

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

    NCT07117240

    10 Jul 2025 to est. 10 Jul 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • lixisenatide + glargineDrug
  • Intensive insulin therapyDrug

Arms2

  • Experimental

    Patients with Steroid-Induced Diabetes

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

  • Experimental

    Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glucose monitoring index and Time in range

    Time frame · From enrollment to 6 months

    Registry description

    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(4)

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

    Time frame · From enrollment to 6 months

  2. Assessment of body mass index (BMI)

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

    Registry description

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

  3. Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire

    Time frame · From enrollment to 6 months

    Registry description

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

  4. 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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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