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Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes Phase 2 105
Clinical Trial NCT06762314 is designed to study Treatment for Diabetes. It is a Phase 2 interventional study that is recruiting, having started on January 20, 2025, with plans to enroll 105 participants. Led by Mostafa Bahaa, it is expected to complete by November 20, 2028. The latest data from ClinicalTrials.gov was last updated on March 13, 2026.
Brief 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 i...Show More
Official Title
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
Conditions
DiabetesOther Study IDs
- Tanta 145
NCT ID Number
Start Date (Actual)
2025-01-20
Last Update Posted
2026-03-13
Completion Date (Estimated)
2028-11-20
Enrollment (Estimated)
105
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorControl group standard treatment group (control) that will be 35 patients who will receive multiply daily injections of insulin (basal/bolus) for 3 months. | Insulin Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy. |
Active ComparatorSemaglutide 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. | Insulin Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy. Semaglutide Semaglutide is long acting glucagon like peptide which is parenterally administered as subcutaneous injection once weekly with a half-life of about 7 days |
Active ComparatorEmpaglflozin group will include 35 patients who will receive empagliflozin 10 mg orally once daily in addition to insulin (basal/bolus) for 3 months. | Insulin Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy. Empagliflozin Empagliflozin lowers blood glucose levels by preventing glucose reabsorption in the kidneys, thereby increasing the amount of glucose excreted in the urine |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment. | The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment. | 3 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
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.
Mostafa Bahaa- Meshal Saud Alotaibi, Senior Clinical Pharmacist, King Salman Speicialist Hospital-Hail, K.S.A.
- Tanta University273 active studies to explore
Study Responsible Party
Mostafa Bahaa, Sponsor-Investigator, Lecturer, Tanta University
No contact data.
1 Study Locations in 1 Countries
Tanta Unuversity, Tanta, 31527, Egypt
Eman I Elberri, PhD, Contact, 0201003592593, [email protected]
Mostafa M Bahaa, PhD, Sub-Investigator
Recruiting