RECRUITINGPhase 2INTERVENTIONAL

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

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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

DRUG

Empagliflozin

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

Locations (1)

Tanta Unuversity

Tanta, Egypt