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Inducing Remission in Type 1 Diabetes with Alefacept (T1DAL)


Purpose

The purpose of this trial is to test whether a drug called alefacept will slow or halt destruction of the beta cells in the pancreas. If the destruction of the beta cells is stopped the patients might be able to produce insulin on their own longer which could stop or slow the progression of their type 1 diabetes.

This proposal is for a multi-center prospective, placebo-controlled, double-blind and randomized, controlled trial to investigate the ability of alefacept to protect residual beta cells in adolescents and young adults with newly diagnosed Type 1 diabetes mellitus from ongoing autoimmune destruction.

 

Ages Eligible for Study:  

12 Years to 35 Years

Genders Eligible for Study:  

Both

Accepts Healthy Volunteers:  

No

Inclusion Criteria:

  • Recent diagnosis of T1DM within 100 days of enrollment.

  • Positive for at least one diabetes autoantibody (Glutamate decarboxylase (GAD-65GAD65), IA2, ZnT8, ICA and Insulin, if obtained within 10 days of the onset of exogenous insulin therapy).

  • Peak stimulated C-peptide level > 0.2 pmol/mL following a mixed-meal tolerance test (MMTT).

  • Willingness to provide written informed consent (either the subject or the subject's legally authorized representative)

For additional information about this trial please call:

Lisa Meyers MSW, CDE  Enrollment Coordinator: 303-724-6893  Lisa.Meyers@ucdenver.edu 

Dominic Di Domenico, Trial Coordinator: 303-724-5687  Dominic.DiDomenico@ucdenver.edu

 

Trial website:  www.T1DAL.org/