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A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus

This study is being done to: • Compare the safety and effects of the study drugs, called empagliflozin and linagliptin with a placebo, in children and adolescents with type 2 diabetes, during the first 26 weeks of this study. A placebo looks like the study drugs but has no drug in it. •Continue to compare the safety of empagliflozin and linagliptin for an additional 26 weeks once all subjects are assigned to receive the active study drugs. Empagliflozin (Jardiance®) and linagliptin (Tradjenta®) have not been approved by the U.S. Food and Drug Administration (FDA) to treat children and adolescents with type 2 diabetes and is experimental for this study. They have been approved by the FDA to treat adults with type 2 diabetes. Patients with Type 2 Diabetes who are currently drug- naïve (not taking any diabetic medications) or patients not on active treatments (including discontinuation of metformin for at least 12 weeks prior to Visit 2) will be asked to come to the CRC for a Screening visit, where study team will go over informed consent. Once consent is signed and dated and by all parties, an EKG, blood draw for safety lab tests, vital signs, height/weight, and a physical exam will be performed. Run-in study drug, home glucose monitoring machine, and patient diary will be given to patient as well as verbal education on all of these devices/materials.
Erica Miller at emiller25@pennstatehealth.psu.edu or 717-531-1278
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Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT03429543
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Inclusion Criteria:
Patients Aged 10-17years
Documented diagnosis of Type 2 diabetes mellitus for at least 8 weeks
DINAMO Mono Hemoglobin A1c greater than 6.5% but not more than 9.0%
Patients not on any active medications for treatment of diabetes for at least 12 weeks prior to visit 2
BMI greater than 85th % for age and gender
Exclusion Criteria:
History of Needle phobia
Female patients who are pregnant
Any antidiabetic medication
Prader-Willi syndrome
Diabetes & Hormones
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Location
Hershey, PA