NCT06762314CompletedPhase 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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 1 Jan 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 20 Jan 2026
- Lead sponsor
- Mostafa Bahaa
- Diseases
- Obesity, Type 1 diabetes
- NCT number
- NCT06762314
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 114
- From 20 Jan 2025 to the primary completion date, 20 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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.
- 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.
Other illness
- 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.
- History of pancreatitis.
- 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.
Lab values
- Liver disease with raised alanine aminotransferase (AST), aspartate transaminase (ALT) or alkaline phosphatase (ALP)more than three times the upper normal range.
Other
- Insulin pump treatment.
- An estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2.
- Gastroparesis.
- Pregnancy or lactation.
- Hypoglycaemia that required hospitalization or emergency treatment in the 3 months.
- DKA that required hospitalization or emergency treatment in the past 12 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta Unuversity Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.