Inducing Remission in Type 1 Diabetes With Alefacept (T1DAL)
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.
Diabetes Mellitus, Type 1
Drug: placebo (saline)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Inducing Remission in New Onset Type 1 Diabetes Mellitus With Alefacept (Amevive®)|
- Mixed-meal tolerance test (MMTT) stimulated 2-hour C-peptide area under the curve (AUC) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
- MMTT-stimulated peak and 4-hour C-peptide AUC [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
- MMTT-stimulated 2-hour C-peptide AUC assessed [ Time Frame: weeks 24, 52 and 104 ] [ Designated as safety issue: No ]
- Insulin use in units per kilogram body weight per day [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
- Major hypoglycemic events occurring from randomization [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
- HbA1C levels [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
- Rate of injection reactions; defined as fever, chills, headache, nausea, vomiting, and injection-site pain in participants receiving alefacept or placebo. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
- Rate of hypersensitivity reactions; defined as signs and symptoms of anaphylaxis, wheezing, dyspnea, urticaria, and hypotension in participants receiving alefacept or placebo. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
- Rate of evidence of infection with Epstein-Barr virus (EBV), Cytomegalovirus (CMV), or Tuberculosis (TB) in participants receiving alefacept or placebo. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
- Frequency and severity of all AEs in participants receiving alefacept or placebo [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (alefacept)
The dose of 15mg via the intramuscular route is the FDA-approved adult dose for psoriasis. In addition 15mg has been used in case series and case reports in children and adolescents successfully without obvious side effects. Dosing and/or schedule may be altered due to the needs of the subject or at the discretion of the physician investigator.
alefacept Intramuscular injection, 15mg weekly for 2 12-week courses (separated by a 12-week pause between)
Other Name: Amevive
Placebo Comparator: Control
IM injection of equal volume and appearance to treatment on the same schedule formulated and prepared by the Emory University Research Pharmacy.
Drug: placebo (saline)
normal saline intramuscular injection, 15mg weekly for 2 12-week courses (separated by a 12-week pause between)
Type 1 Diabetes Mellitus (T1DM) is an autoimmune disease that can emerge suddenly causing dependence on insulin for life. This means that your immune system (the part of your body that helps fight infections) mistakenly attacks the cells in the pancreas that produce insulin (beta cells). As beta cells are destroyed, your ability to produce insulin is decreased. Insulin helps keep blood glucose (sugar) levels normal.
For a period right after diagnosis, your pancreas is still able to make small amounts of insulin. People with diabetes who have the ability to produce some of their own insulin may be able to achieve better blood sugar control than people who produce no insulin at all. Based on previous research, doctors think that giving medicines to affect the immune system soon after diagnosis may stop, delay, or decrease the destruction of beta cells, resulting in better glucose control. This can help prevent secondary complications of diabetes down the road.
Doctors are investigating how to save the insulin producing cells and extend the honeymoon period as long as possible. But research has dramatically improved the outlook for type 1 diabetes over the last decade.
Despite progress towards understanding the science behind T1DM, there still remains a significant need to investigate alternative approaches to type 1 diabetes in order to bring about long-term remission in this condition. For this reason, scientists are working hard to develop new treatments that can be given soon after diagnosis to preserve the remaining beta cells.
At the moment there is no cure. But with new investigational mediations and innovative clinical research studies, such as T1DAL, a new approach towards managing type 1 diabetes may be on the horizon.
Enrollees will receive weekly intramuscular injections of alefacept or placebo for two 12 week periods, with a 12-week pause between. This schedule or drug dosing may be altered due to the needs of the subject or at the discretion of the physician investigator.
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|Principal Investigator:||Mark R Rigby, MD, PhD||Indiana University|