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

Phase 2

Not yet recruiting

• Conditions: Diabetes
• Interventions: Drug: Insulin; Drug: Semaglutide; Drug: Empagliflozin

• Registration Number: NCT06762314
• Lead Sponsor: Mostafa Bahaa

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-01-20
• Primary Completion: 2027-09-20
• Study Completion: 2028-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Insulin	standard treatment group (control) that will be 35 patients who will receive multiply daily injections of insulin (basal/bolus) for 3 months.
Semaglutide group	Insulin	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.
Semaglutide group	Semaglutide	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.
Empaglflozin group	Insulin	will include 35 patients who will receive empagliflozin 10 mg orally once daily in addition to insulin (basal/bolus) for 3 months.
Empaglflozin group	Empagliflozin	will include 35 patients who will receive empagliflozin 10 mg orally once daily in addition to insulin (basal/bolus) for 3 months.

Primary Outcome Measures

Name	Time	Method
The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment.	3 months	The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment.

Trial Locations

Locations (1)

Tanta Unuversity; 🇪🇬 Tanta, Egypt