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

March 12, 2026 updated by: Mostafa Bahaa

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 31527
        • Recruiting
        • Tanta Unuversity
        • Sub-Investigator:
          • Mostafa M Bahaa, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Insulin
Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy.
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.
Drug: Insulin
Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy.
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
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.
Drug: Insulin
Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy.
Drug: Empagliflozin
Empagliflozin lowers blood glucose levels by preventing glucose reabsorption in the kidneys, thereby increasing the amount of glucose excreted in the urine

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mostafa Bahaa

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

November 20, 2028

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tanta 145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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