Summary:
Type 1 Diabetes Mellitus (T1DM) is an autoimmune disease that occurs when the pancreas produces little or no insulin. Insulin is a hormone that functions to regulate blood glucose levels. The purpose of this research study is to learn about the effects of the study drug, PF-063426744, and to find the best dose for treating T1DM. This is a Phase 1 study. In Phase 1 studies researchers test an investigational drug in a small group of people with the disease to evaluate its safety, determine a safe dosage range, and identify side effects. The dose of the experimental drug is gradually increased during Phase 1 clinical studies to allow the investigator to measure the research participant's response to the drug, whether the drug is sufficiently absorbed, how long the drug remains in the bloodstream after dosing, and which dosage levels are safe and well tolerated.
- There will be between 16 and 20 clinic visits over a 5 month period.
- Participants will have screening tests including hepatitis, tuberculosis, and HIV, all must be negative to participate in this study.
- Participants will receive physical exams, lab tests (blood & urine), meal tolerance tests, and keep an insulin dosage and self-measure blood glucose test diary.
- Parking is free and if the participant takes the Metro, fare will be reimbursed.
- Patients will receive $135 for each completed clinic visit to cover travel and inconvenience for a total of up to $2700 if all visits are completed
- Participant’s primary care doctor will be notified of participation with participant’s permission.
Qualified Participants Must:
• Have type 1 diabetes diagnosed within the past 2 years
•
Be taking insulin and no other diabetes medications