Therapeutic targets in African-American youth with type 2 diabetes

National Institute Of Diabetes And Digestive And Kidney Diseases

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Linked publications & trials

Abstract

This study design is a parallel-randomized intervention trial of African-American youth with type 2 diabetes who are not on insulin therapy and who are within 3 years of diagnosis. Patients aged 12-21 years with type 2 diabetes will be enrolled. Participants will be randomized into two intervention arms (16 in each group): metformin and liraglutide versus metformin alone. The study will consist of 5 visits. At Visit 1, a medical history, physical examination and screening labs will be done. Then the eligible participants will undergo a one-week drug-free run-in. At Visit 2 there will be an overnight inpatient stay to perform metabolic testing prior to starting the study drug(s). Participants will start the study drug(s) immediately after Visit 2 and remain on the study drug(s) for 12 weeks. Follow-up monitoring will be performed at 4 week intervals (Visit 3 and 4). The final visit (Visit 5) will occur after 12 weeks. This study received the NIH Clinical Center Bench-to-Bedside Award in 2016. The protocol is under IRB review and we anticipate that recruitment will start in the coming months.