Actively Recruiting
Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes
Led by Mostafa Bahaa · Updated on 2026-03-13
105
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
M
Mostafa Bahaa
Lead Sponsor
M
Meshal Saud Alotaibi, Senior Clinical Pharmacist, King Salman Speicialist Hospital-Hail, K.S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 1 diabetes for more than 1 year
- Age between 18 and 65 years
- Body mass index (BMI) of 27 kg/m² or higher
- Glycated hemoglobin (HbA1c) between 7.5% and 10%
- Inadequately controlled despite multiple daily insulin injections for at least 1 year
You will not qualify if you...
- History of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) syndrome or related family history
- Use of insulin pump treatment
- Previous use of GLP-1 receptor agonists or dipeptidyl peptidase-4 inhibitors, or other medications affecting glycemic control except insulin
- Estimated glomerular filtration rate ≤ 30 mL/min/1.73 m²
- Liver disease with liver enzymes more than three times the normal upper limit
- History of pancreatitis
- Gastroparesis
- Pregnancy or lactation
- History of alcohol or drug misuse or medical/psychological conditions unsuitable for study
- Acute symptomatic urinary tract or genital infection or chronic/recurrent cystitis
- Hypoglycemia requiring hospitalization or emergency treatment in the past 3 months
- Diabetic ketoacidosis requiring hospitalization or emergency treatment in the past 12 months
- Treatment with anti-obesity drugs, weight-loss surgery, or aggressive diet causing unstable weight in the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tanta Unuversity
Tanta, Egypt, 31527
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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