Partners For Better Health In Adolescent Type 2 Diabetes: The Buddy Study

ClinicalTrials.gov Identifier: NCT01007266

This study is based on data showing that type 2 diabetes is becoming increasingly common in adolescents and that behavioral and lifestyle factors often make diabetes control poor among this group. It will look at whether assigning subjects a “patient buddy” can help improve diabetes control and quality of life. Participants (12-20 years old with A1c values >7%) will be randomized to receive either standard care or to be assigned a “buddy” – the study is seeking 120 participants in the Washington DC/Maryland area, and the study will last six months. Patients in the buddy group will get weekly phone or online messages from their buddies and meet with them in person once a month. It is hoped that contact with this buddy, who will not be a health care professional and will not provide medical advice, will help participants better adhere to treatment. The study will last six months, and after its completion, researchers will look at whether those patients who were assigned a “buddy” had better A1c levels or had improvements in body weight, glucose monitoring, adherence to medication, or attendance of doctors’ visits. This trial is unique because it digs deep into what some of the determinants of adherence to treatment are for teenagers. If it finds that simply having a “buddy” who checked up on their progress or supported them in their treatment made a difference, it would present a simple but innovative way to ensure better care for teenage patients with type 2 diabetes. --LR

Canakinumab In Patients With Impaired Glucose Tolerance Or Patients With Type 2 Diabetes

ClinicalTrials.gov Identifier: NCT01068860

This phase 2 study will look at the effects of Novartis's canakinumab (Ilaris), an IL-1beta monoclonal antibody, in patients already receiving standard treatment for impaired glucose tolerance or type 2 diabetes (metformin alone; metformin and sulfonylureas; metformin, sulfonylureas, and thiazolidinediones; or insulin). Canakinumab is part of the family of IL-1beta inhibitors - IL-1beta is a molecule heavily involved in inflammation and cell death, and it is thought that blocking it could stop the beta cell loss seen in type 2 diabetes. The drug will be administered in conjunction with a patient's current type 2 diabetes therapy with the hope that Ilaris enhances control. The study will primarily look at a patient's post-meal insulin production after four weeks of being on the drug, and will hopefully provide valuable safety information as well. The drug is already FDA-approved for CAPS (cryopyrin-associated periodic syndromes), other conditions involving inflammation, and is also being tested in people with rheumatoid arthritis. This trial started enrolling in early 2010 and hopes to enroll 232 patients total. It is recruiting at 53 locations worldwide. Those interested in the study should contact Novartis Pharmaceuticals at 862-778-8300. --LR