Status:
WITHDRAWN
Empagliflozin in Adolescent Diabetes
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Diacomp
Conditions:
type1diabetes
Eligibility:
All Genders
12-18 years
Phase:
PHASE4
Brief Summary
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 cardiovascu...
Detailed Description
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 Wexne...
Eligibility Criteria
Inclusion
- Age: 12-18 years
- Clinical diagnosis of type 1 diabetes
- Duration of diabetes \> 1 r
- Multiple daily injections or continuous subcutaneous insulin infusion.
- Home glucose testing 4 times per day or continuous glucose monitor.
- Hemoglobin A1c levels will be ≤ 10.5%
- History of adherence to insulin administration, carbohydrate counting.
Exclusion
- Duration of type 1 diabetes for less than 1 year
- Medical conditions other than type 1 diabetes or treated hypothyroidism
- Medications other than insulin, levothyroxine or oral contraceptives for birth control
- Antihypertensive medications, lipid lowering medications, or anti-hyperglycemic agents other than insulin.
- Acute viral and bacterial illnesses are not exclusionary, but we will take a health history at baseline and at the time of any study visit and if a recent illness has occurred we will delay testing until the individual is symptom free for 1 week and off and treatment for the illness.
- Hospital admission for diabetic ketoacidosis in the last year
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04917692
Start Date
July 1 2021
End Date
October 1 2022
Last Update
March 23 2023
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210