RecruitingPhase 2

Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes

Comparative Clinical Study to Evaluate the Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes Inadequately Controlled by Insulin Therapy

Lead sponsor

Mostafa Bahaa

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

105

Study population

Obesity / overweight, Type 1 diabetes

Eligibility highlights

•BMI ≥27•HbA1c 7.5-10%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06762314

Org study IDTanta 145

Timeline

Milestones

Study first posted2025-01-07actual

Study start2025-01-20actual

Last update posted2026-03-13actual

Primary completion2027-09-20estimated

Study completion2028-11-20estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•patients diagnosed with type 1 diabetes for more than 1 year.

•Age 18-65 years.

•BMI ≥ 27 kg/m².

•HbA1c 7.5-10 % (58-86 mmol/mol)

•Inadequately controlled despite treatment with multiple daily injections of insulin for at least 1 year.

Exclusion criteria

History of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) syndrome; family history of multiple endocrine neoplasia, type 2A (MEN 2A), medullary thyroid cancer, or familial medullary thyroid cancer.

•Insulin pump treatment.

•Any prior use of GLP-1 RAs or dipeptidyl peptidase-4 inhibitors, any medication (except insulin) that could interfere with glycemic control or affect a subject's safety.

•An estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2.

•Liver disease with raised alanine aminotransferase (AST), aspartate transaminase (ALT) or alkaline phosphatase (ALP)more than three times the upper normal range.

•History of pancreatitis.

•Gastroparesis.

•Pregnancy or lactation.

•History of alcohol or drug misuse, or any medical or psychological disorder that made the patient unsuitable for study participation.

•Acute symptomatic urinary tract infection or genital infection; chronic or recurrent (≥3 annual episodes) cystitis.

•Hypoglycaemia that required hospitalization or emergency treatment in the 3 months.

•DKA that required hospitalization or emergency treatment in the past 12 months.

•Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen leading to unstable body weight (based on Investigator's judgement) for the last 3 months.

Endpoints (1)

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.

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment.

Time frame:3 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.