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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Tanta Unuversity
RECRUITING
Tanta
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2028-11-20
Participants
Target number of participants: 105
Treatments
Active_comparator: Control group
standard treatment group (control) that will be 35 patients who will receive multiply daily injections of insulin (basal/bolus) for 3 months.
Active_comparator: Semaglutide group
will include 35 patients who in addition to insulin (basal/bolus) will receive semaglutide 0.25 mg Sc once weekly for 1 month then increase to 0.5 mg SC once weekly for 2 months.
Active_comparator: Empaglflozin group
will include 35 patients who will receive empagliflozin 10 mg orally once daily in addition to insulin (basal/bolus) for 3 months.
Related Therapeutic Areas
Sponsors
Leads: Mostafa Bahaa
Collaborators: Tanta University, Meshal Saud Alotaibi, Senior Clinical Pharmacist, King Salman Speicialist Hospital-Hail, K.S.A.

This content was sourced from clinicaltrials.gov