Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
NCT02960659 · Completed
Last updated 2026-05-28This clinical trial tests different treatment approaches in African-American youth aged 12 to 17 who have type 2 diabetes to see how their bodies process glucose over a 12-week period.
What this study is testing ClinicalTrials.gov NCT02960659 ↗
Description as written by the study sponsor.
Background: The pill metformin treats diabetes. But it does not work for all youth, especially African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers want to understand how these drugs work and if they decrease excess sugar made by the liver in youth with type 2 diabetes. Objective: To test if using liraglutide and metformin are better than just metformin for decreasing excess sugar produced by the liver in African-American youth with type 2 diabetes. Eligibility: African-Americans ages 12-25 with type 2 diabetes Design: Visit 1: Participants will be screened with medical history, physical exam, and blood and urine tests. Participants will stop taking diabetes medicines for 1 week. They will learn how to check blood sugars at home twice a day. Visit 2: Overnight at the clinic. Participants will have: Vital signs taken. Pregnancy test. A thin plastic tube (IV catheter) be inserted in each forearm by needle. Blood drawn several times after drinking a sweet drink. X-ray of total body fat. Urine and stool collected. Breath tests while wearing a clear hood for up to 45 minutes. For several hours, participants can have only water. At 4 a.m. they will get sugar and fat with nonradioactive isotopes in one IV. Blood will be collected. Every 30 minutes from 9 a.m. to 2 p.m., they will drink small amounts of a shake and have blood drawn. Participants will be randomly assigned to take either both study drugs daily or just metformin daily. Visits 3-4: Participants will bring their blood sugar records and have blood tests. Visit 5, after 3 months: Repeat of visit 2....
Treatments tested
- Liraglutide Drug
Liraglutide (6mg/ml, 3ml ) solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6mg, 1.2mg or 1.8mg.
- Metformin Drug
Metformin 500mg oral tablet
| Main thing measured | Change in Absolute Gluconeogenesis From Baseline to 12 Weeks |
|---|---|
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Conditions studied | Type 2 Diabetes |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02960659 ↗