RecruitingPhase 2NCT06762314

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


Sponsor

Mostafa Bahaa

Enrollment

105 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Type 1 Diabetes (T1DM) is a disease characterised by immune mediated destruction of the insulin-producing pancreatic beta cells. Overtime, obvious insulin deficiency develops which requires insulin therapy. T1DM accounts for about 5% to 10% of diabetes cases in Europe and United States. Currently, worldwide incidence is estimated to be around 15 per 100,000 people per year. Despite the advancement that has occurred in the field diabetes therapy, patient with T1DM still suffer from managing their disease as well as continuing to face diabetes related complications. The American Diabetes Association (ADA) recommend a goal of glycated haemoglobin (HbA1c) of \< 7%. However, only 21% of adults in the United States has achieved this recommended goal. Once again, a multinational, multicentre study shows that only 24.3% of participants achieved the glycaemic target of HbA1c less than 7.0 %. Unfortunately, intensifying the insulin therapy in order to reach the targeted HbA1c can result in serious adverse effects of hypoglycaemia and weight gain which is in its turn is known risk factor for cardiovascular disease.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether two diabetes drugs — empagliflozin (an SGLT2 inhibitor) and semaglutide (a GLP-1 receptor agonist) — can help overweight or obese people with type 1 diabetes achieve better blood sugar control. **You may be eligible if...** - You have had type 1 diabetes for more than 1 year - You are between 18 and 65 years old - Your BMI is 27 or higher (overweight or obese) - Your HbA1c (average blood sugar level) is between 7.5% and 10% - You use multiple daily insulin injections (not an insulin pump) - Your blood sugar remains poorly controlled despite insulin therapy for at least 1 year **You may NOT be eligible if...** - You have a personal or family history of medullary thyroid cancer or a condition called MEN2 - You use an insulin pump - You have used GLP-1 drugs or DPP-4 inhibitors before - You have severely reduced kidney function or active liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInsulin

Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy.

DRUGSemaglutide

Semaglutide is long acting glucagon like peptide which is parenterally administered as subcutaneous injection once weekly with a half-life of about 7 days

DRUGEmpagliflozin

Empagliflozin lowers blood glucose levels by preventing glucose reabsorption in the kidneys, thereby increasing the amount of glucose excreted in the urine


Locations(1)

Tanta Unuversity

Tanta, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06762314


Related Trials