Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06762314

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Eman I Elberri, PhD

CONTACT

[email protected]

0201003592593

Mostafa M Bahaa, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug

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

semaglutide

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

Empagliflozin

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mostafa Bahaa

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 7, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.