A Phase 4 interventional study of Empagliflozin in type1diabetes, sponsored by Ohio State University. Withdrawn at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Ohio State University · Phase 4, Interventional, and Treatment
Empagliflozin, an inhibitor of the sodium glucose co-transporter 2 (SGLT2), reduces post-prandial glucose levels in adults with both type 2 and type 1 diabetes and importantly reduces both cardiovascular and renal complications in type 2 diabetes. In adults with type 1 diabetes empagliflozin improves endothelial function and vascular stiffness when used in conjunction with insulin. There is clear evidence that complications in type 1 diabetes have their origins during adolescents thus to reduce diabetic complications with adjunctive therapy, this age group must be studied. These studies will need to focus on the effects of these adjunctive agents on functional biomarkers for development of complications. This study is designed to develop pilot and feasibility data for a large scale trial of low dose empagliflozin, 2.5 mg daily, on biomarkers for the development of cardiovascular and renal complications in adolescents between 12 and 18 years of age. The investigators will specifically study the effects of 8 weeks of empagliflozin on:
The investigators will, also, measure more traditional risk markers including blood pressure, hemoglobin A1c, and lipids. Eligible participants will have had diabetes for at least 1 year and not have other chronic medical illnesses or diabetes complications. Because of the risk of diabetic ketoacidosis (DKA) subjects must have a hemoglobin A1c level less than 9% and have no history of recurrent DKA or known insulin omission. This will be the first pilot study designed to explore primary endpoints regarding cardiovascular and renal disease rather than glucose control with empagliflozin therapy in adolescents with type 1 diabetes.
This is an 8 week single arm trial on the effects of empagliflozin 2.5 mg in adolescents with type 1 diabetes for at least 1 year. Subjects will be studied in the Clinical Research Center of the Wexner Medical Center at the Ohio State University 3 times. Visit 0 will be the initial study visit and will involve obtaining informed consent and assent, taking a medical history and performing a physical examination. Over the next 2 weeks the subjects will be contacted by the investigators to adjust insulin doses.
Visit 1 will be the baseline visit. It will occur at 8AM after an overnight fast. Blood samples will be collected to measure inflammatory markers will be collected and vascular function will be tested. Subjects will then be given premeal insulin and a breakfast. Following this, additional blood samples and vascular function measurements will be taken at 30, 60, 90, and 120 minutes.
After completion of the tests home insulin doses will be reduced and the subjects will be given empagliflozin 2.5 mg daily to take at home for the next 8 weeks. They will be instructed regarding potential side effects including diabetic ketoacidosis and genital infections.
Subjects will be contacted regularly by the investigators during these 8 weeks to review home glucose monitoring and potential side effects. After completion of the 8 weeks Visit 2 will occur which will be identical Visit 1.
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Exclusion Criteria:
empagliflozin 2.5 mg daily
Drug: Empagliflozin
2.5 mg daily
Also known as: Jardiance
Interleukin 6
IL6 levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Time frame: 8 weeks
Glomerular filtration rate
Cystatin C levels will be used to calculate GFR before and after high carbohydrate meal at the beginning and end of the 8 weeks
Time frame: 8 weeks
Endothelial function
Percentage change in forearm vascular resistance following 5 min of arterial occlusion.
Time frame: 8 weeks
Number of episodes of diabetic ketoacidosis per patient
Frequency of diabetic ketoacidosis will be assessed through the 8 weeks
Time frame: 8 weeks
Complement
Complement component C3 and C4 levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Time frame: 8 weeks
Lipids
Lipid levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Time frame: 8 weeks
Pulse wave velocity
Pulse wave velocity will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Time frame: 8 weeks
Number of episodes of hypoglycemia per patient
Frequency of hypoglycemia will be assessed over 8 weeks
Time frame: 8 weeks
Plan to share: No
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This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Ohio State University