Testing Empagliflozin and Semaglutide for Weight Management in 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

This study is testing if two medications, Empagliflozin and Semaglutide, can help adults with Type 1 Diabetes who are overweight or obese manage their weight and improve blood sugar control.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Locations: 1 site (Tanta)
• Trial ID: NCT06762314 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of two medications, Empagliflozin and Semaglutide, in overweight or obese patients diagnosed with Type 1 Diabetes. The study aims to determine if these treatments can help improve glycemic control and manage weight in individuals who have struggled to achieve their target HbA1c levels despite insulin therapy. Participants will be adults aged 18-65 with a BMI of 27 kg/m² or higher and an HbA1c between 7.5% and 10%. The trial will exclude individuals with certain medical histories or conditions that may interfere with the treatment's effectiveness or safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with Type 1 Diabetes for over a year, a BMI of 27 kg/m² or higher, and an HbA1c between 7.5% and 10%.

Not a fit: Patients with a history of certain cancers, pancreatitis, or those currently using insulin pumps or specific diabetes medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide new treatment options for managing Type 1 Diabetes in overweight or obese patients, potentially improving their overall health and quality of life.

How similar studies have performed: While there have been studies on diabetes management with GLP-1 receptor agonists and SGLT2 inhibitors, this specific combination approach in Type 1 Diabetes is relatively novel.

Eligibility criteria

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.

Where this trial is running

Tanta

• Tanta Unuversity — Tanta, Egypt (Recruiting)

Conditions Diabetes