Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes

NCT ID: NCT06762314

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2028-11-20

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 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

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

standard treatment group (control) that will be 35 patients who will receive multiply daily injections of insulin (basal/bolus) for 3 months.

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

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

Semaglutide

Intervention Type: DRUG

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

Empaglflozin group

will include 35 patients who will receive empagliflozin 10 mg orally once daily in addition to insulin (basal/bolus) for 3 months.

Group Type: ACTIVE_COMPARATOR

Insulin

Intervention Type: DRUG

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

Empagliflozin

Intervention Type: DRUG

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

Interventions

Insulin

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Empagliflozin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshal Saud Alotaibi, Senior Clinical Pharmacist, King Salman Speicialist Hospital-Hail, K.S.A.

UNKNOWN

Sponsor Role: collaborator

Tanta University

OTHER

Sponsor Role: collaborator

Mostafa Bahaa

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tanta Unuversity

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Eman I Elberri, PhD

Role: primary

mbahaa@horus.edu.eg

0201003592593

Other Identifiers

Tanta 145

Identifier Type: -

Identifier Source: org_study_id