T1DAL: Alefacept in new-onset type 1 diabetes
What this study tests
Phase-2 trial targeting CD2-high memory T cells with alefacept. The 12-month primary 2-hour C-peptide endpoint was not significant, but 4-hour C-peptide, insulin use, hypoglycemia and 24-month outcomes favored treatment.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2017-07-06.
Most recent recorded citation date: 2017-07-06. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Ages 12-35 within 100 days of T1D diagnosis. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- The primary 12-month 2-hour C-peptide endpoint was not significant (P=0.065), but key secondary measures favored alefacept. At 24 months, both 2-hour and 4-hour C-peptide AUCs were significantly greater, insulin use was lower, and major hypoglycemia was about 50% lower.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Change from baseline in 2-hour mixed-meal stimulated C-peptide AUC at 12 months
The full picture
The registry records termination because the manufacturer stopped producing Amevive for a business reason, not because this trial demonstrated futility. Forty-nine people participated.
The 12-month primary two-hour C-peptide endpoint was not statistically significant. Later and secondary signals remain exploratory evidence for memory-T-cell targeting; alefacept is not an available T1D treatment. See the linked primary reports and registry for the analyses and withdrawal context.
Sources
- [1]Targeting of memory T cells with alefacept in new-onset type 1 diabetes · Peer-reviewed study · 2013-09-23
- [2]Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients · Peer-reviewed study · 2015-07-20
- [3]Inducing Remission in Type 1 Diabetes With Alefacept · Trial registry · 2017-07-06