In this study we are testing a new drug called teplizumab to see if it can help protect the cells that make insulin in people with type 1 diabetes. We want to know if it can improve blood sugar levels, reduce the need for extra insulin, and lower the risk of low blood sugar.
There are two groups in this study so that we can compare how well teplizumab works. Group 1 will receive the study drug teplizumab through an IV infusion. Group 2 will receive a placebo through an IV infusion. A placebo is an inactive substance that looks the same and is given the same way as the study drug. You/your child will be randomly assigned to one of the groups, like flipping a coin. If you/your child join this study, you will come to about 37 visits over the course of 18 months at the Barbara Davis Center on the CU Anschutz campus. At these visits we will ask about you/your child’s health and do physical exams. We will measure height, weight, and vital signs. We will also take blood samples from you/your child’s arm with a needle. We will ask you/your child to wear a continuous glucose monitor at different times throughout the study. If you/your child completes all parts of the study, you will be paid up to $4,500.
You/your child may be able to join this study if you are between 1 and 25 years old. You/your child must have been diagnosed with type 1 diabetes within 8 weeks of joining the study. If you/your child are interested in joining this study, we will do other tests to make sure you meet all requirements and that it is safe for you to join.
Protocol Number: 25-0693
Kimberly Simmons, MD, MPH/MSPH
Principal Investigator