This trial is testing whether repeated injections of an investigational study drug called alefacept (also called Amevive ®) will help people with newly-diagnosed type 1 diabetes continue to make some of their own insulin.
T1DAL (Inducing Remission in New-onset Type 1 Diabetes with Alefacept) is a phase II clinical research trial in which the investigational study drug (alefacept) is tested for safety and whether it is effective in slowing or halting the progression of type 1 diabetes.
This trial plans to enroll 66 participants at approximately 20 clinical research centers across the U.S.
About the investigational study drug
In this trial, doctors will be testing whether alefacept (Amevive ®) will slow or halt the destruction of beta cells in the pancreas that occurs in type 1 diabetes. Alefacept (Amevive ®) is a medication which subdues the immune system. Although alefacept (Amevive ®) has never been tested in patients with diabetes, it has already been approved by the FDA for use in the treatment of an autoimmune skin disorder called psoriasis. Therefore, the use of alefacept in this trial is considered an experimental treatment.
What does participation involve?
Participants will be randomly assigned to one of two groups. One group will be given the study drug, alefacept, and the other group will receive an inactive substance made to look like the study drug, called a placebo.
Two-thirds of the people in this study will get shots of alefacept. One third of the people in the study will get shots of the placebo. You cannot choose your group. A computer randomly picks who gets the study drug and who gets placebo.
This study is double-blinded. This means that while the study is going on, neither you nor your study team will know who gets the study drug and who gets placebo. At the end of the study, we will tell you which group you were in.
Alefacept or the placebo is given by shot once a week in two 12-week periods.
|Cycle 1||3 months (12 weeks)||Clinic visits once a week (shots once a week)|
|Trial Pause||3 months||Clinic visits once a month|
|Cycle 2||3 months (12 weeks)||Clinic visits once a week (shots once a week)|
|Follow-up||Approx. 15 months||Clinic visits once every 6 months|
- Study participants will receive a total of 24 intramuscular injections over the course of the trial
- Total participation in this trial will last about two years
- Regardless of whether you receive the experimental treatment or placebo, all T1DAL participants will receive intensive diabetes management from expert medical staff, with the goal to keep blood glucose levels as close to normal as possible
- Compensation for travel and related expenses may be available for participants—T1DAL staff can provide additional details
- Study-related diabetes supplies and care will be provided at no cost to participants