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

ConditionDiabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMostafa Bahaa

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Insulin
  • Semaglutide
  • Empagliflozin

Treatment groups

105 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Mostafa Bahaa

Lead sponsor

Tanta University

Sponsor institution

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

Collaborator

Tanta University

Collaborator