Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes
Recruiting
Phase 2Interventional Study
Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Mostafa Bahaa · Other
Who this trial is looking for
This trial is looking for overweight or obese adults with type 1 diabetes who have not been able to manage their blood sugar levels with insulin. Participants will be given either empagliflozin or semaglutide to see if it helps improve their condition.
Are You a Good Fit for This Trial?
Must be takingInsulin
Rules you outMedullary thyroid carcinomaMultiple endocrine neoplasia type 2PancreatitisLiver diseasePregnancy
You may be able to join if
I have been diagnosed with type 1 diabetes for more than 1 year.
I am between 18 and 65 years old.
My BMI is 27 or higher.
My HbA1c is between 7.5% and 10%.
I have not controlled my diabetes well despite using multiple daily injections of insulin for at least 1 year.
You may not be able to join if
I have a history of medullary thyroid cancer.
I have ever used an insulin pump.
I have used GLP-1 RAs or DPP-4 inhibitors.
My kidney function is severely reduced (eGFR ≤ 30 mL/min/1.73 m2).
I have liver disease with elevated liver enzymes.
I have a history of pancreatitis.
I am pregnant or breastfeeding.
I have had a severe low blood sugar event requiring hospitalization in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
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 medu…
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.
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