Steroid-Induced DiabetesPhase 4NCT07117240
Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes
A Phase 4 study testing lixisenatide + glargine and Intensive insulin therapy in people with Steroid-Induced Diabetes and Steroid-Induced Hyperglycemia, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steroid-Induced Diabetes, Steroid-Induced Hyperglycemia, Diabetes
- What is being tested?
- lixisenatide + glargine and Intensive insulin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jul 2025to 10 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- Psoriatic arthritis
- Polymyalgia rheumatica
- Synovitis associated with osteoarthritis
- Sarcoidosis
- Tubulointerstitial nephritis
- Atopic dermatitis
- Pemphigus
- Informed consent
Who cannot join
- - 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Treatment Strategies for Steroid-induced Diabetes - a Comparison of GLP-1 Receptor Agonist Plus Basal Insulin With Intensive Insulin Therapy
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.
Read the 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.
- Being tested
- lixisenatide + glargine, Intensive insulin therapy
- Keywords
- Steroid-induced diabetes, GLP-1 receptor agonist, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lixisenatide + glargineDrug
Also called 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.
Intensive insulin therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Steroid-Induced Diabetes | Experimental | Patients diagnosed with Steroid-induced diabetes, that require insulin therapy Receives: 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 Receives: Drug: lixisenatide + glargine; Drug: Intensive insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From enrollment to 6 months
Assessment of body mass index (BMI)
weight and height will be combined to report BMI in kg/m^2
Measured: 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.
Measured: 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.
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start10 Jul 2025
- Primary completion9 Feb 2028 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-Induced DiabetesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Jedrasek, Medical University of Warsaw
- Investigators
- Leszek Czupryniak, Prof. Dr. hab.n.med., Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117240
- Sponsor's protocol ID
- KB/113/2025
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment Strategies for Steroid-induced Diabetes - a Comparison of GLP-1 Receptor Agonist Plus Basal Insulin With Intensive Insulin Therapy
- ClinicalTrials.gov ID
- NCT07117240
- Acronym / sponsor ID
- KB/113/2025
- Keywords
- Steroid-induced diabetes, GLP-1 receptor agonist, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 9 Feb 2028 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Steroid-Induced Diabetes | Experimental | Drug: lixisenatide + glargine, Drug: Intensive insulin therapyPatients diagnosed with Steroid-induced diabetes, that require insulin therapy |
| Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia | Experimental | Drug: lixisenatide + glargine, Drug: Intensive insulin therapyPatients with history of type 2 diabetes, that developed Steroid-induced hyperglycaemia and require insulin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lixisenatide + glargineAlso: GLP-1 plus basal insulinParticipants 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 | Patients with Steroid-Induced Diabetes, Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia |
| Intensive insulin therapyParticipants 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 | Patients with Steroid-Induced Diabetes, Patients with type 2 diabetes and Steroid-Induced Hyperglycaemia |
Primary outcome
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)
4 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
Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire
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
Time frame: From enrollment to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leszek Czupryniak, Prof. Dr. hab.n.med. study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lixisenatide + glargine and Intensive insulin therapy in people with Steroid-Induced Diabetes and Steroid-Induced Hyperglycemia, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose monitoring index and Time in range (time frame: From enrollment to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.