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Enrolling by invitationPhase 4

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

Efficacy of Treatment Strategies for Steroid-induced Diabetes - a Comparison of GLP-1 Receptor Agonist Plus Basal Insulin With Intensive Insulin Therapy

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

100

estimated

Study population

Diabetes (other / unspecified), Type 2 diabetes

Key I/E criterion

Primary endpoint

CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07117240
Org study IDKB/113/2025

Timeline

Milestones

Study start2025-07-10actual
Study first posted2025-08-12actual
Last update posted2025-09-19actual
Primary completion2028-02-09estimated
Study completion2028-07-10estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Diabetes (other / unspecified)Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Weight & body composition
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Assessment of body mass index (BMI)

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

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Glucose monitoring index and Time in range

Time frame:From enrollment to 6 months

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:From enrollment to 6 months

threshold achievement, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Patient satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire

Time frame:From enrollment to 6 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.