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Tests treatment safety and results for Diabetes
Official title Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06762314
What this study is testing
What is Insulin?
Insulin is an investigational medicine, being studied as a potential treatment for diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- History of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) syndrome; family history of multiple endocrine neoplasia, type...
- 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...
- 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...
- History of pancreatitis.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tanta, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tanta, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.