Inducing Remission in Type 1 Diabetes With Alefacept
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 1
Intervention: alefacept (Drug); placebo (saline) (Drug)
Phase: Phase 2
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Official(s) and/or principal investigator(s):
Mark R Rigby, MD, PhD, Principal Investigator, Affiliation: Emory University
Stephanie Meisner, RN, BSN, Phone: (404) 785-6453, Email: email@example.com
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.
Official title: Inducing Remission in New Onset Type 1 Diabetes Mellitus With Alefacept (Amevive®)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mixed-meal tolerance test (MMTT) stimulated 2-hour C-peptide area under the curve (AUC)
MMTT-stimulated peak and 4-hour C-peptide AUC
MMTT-stimulated 2-hour C-peptide AUC assessed
Insulin use in units per kilogram body weight per day
Major hypoglycemic events occurring from randomization
Rate of injection reactions; defined as fever, chills, headache, nausea, vomiting, and injection-site pain in participants receiving alefacept or placebo.
Rate of hypersensitivity reactions; defined as signs and symptoms of anaphylaxis, wheezing, dyspnea, urticaria, and hypotension in participants receiving alefacept or placebo.
Rate of evidence of infection with Epstein-Barr virus (EBV), Cytomegalovirus (CMV), or Tuberculosis (TB) in participants receiving alefacept or placebo.
Frequency and severity of all AEs in participants receiving alefacept or placebo
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
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
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.
Minimum age: 12 Years.
Maximum age: 35 Years.
- 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
- Willingness to provide written informed consent (either the subject or the subject's
legally authorized representative)
- Severe reaction or anaphylaxis to human monoclonal antibodies.
- History of malignancy or significant cardiovascular disease (including history of
myocardial infarction, angina, use of anti-anginal medicines (e. g., nitroglycerin),
or abnormal stress test).
- History of recent or ongoing uncontrolled bacterial, viral, fungal, or other
- Evidence of infection with HBV (as defined by hepatitis B surface antigen, HBsAg),
HCV (anti-HCV antibodies), HIV or toxoplasmosis.
- Positive tuberculin skin test (PPD).
- Clinically active infection with EBV, CMV, or tuberculosis; or EBV viral load â‰¥
10,000 copies per 106 PBMCs or CMV viral load â‰¥10,000 copies per mL whole blood.
- Diagnosis of liver disease or hepatic enzymes, as defined by ALT and/or AST â‰¥ 2 times
the upper limit of normal.
- Prior or current treatment that is known to cause a significant, ongoing change in
the course of T1DM or immunologic status, including high-dose inhaled, extensive
topical or systemic glucocorticoids.
- Current or prior (within the last 30 days) use of metformin, sulfonylureas, glinides,
thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.
- Current use of any medication known to influence glucose tolerance (e. g., atypical
antipsychotics, diphenylhydantoin, thiazide, or other potassium-depleting diuretics,
Î²-adrenergic blockers, niacin).
- Any of the following hematologic abnormalities, confirmed by repeat tests at least 1
1. White blood count <4000/Î¼L or >14,000/Î¼L;
2. CD4+ count below the lower limit of normal;
3. Platelet count <150,000 /Î¼L; or
4. Hemoglobin <10 g/dL.
- Females who are pregnant, lactating, or planning on pregnancy during the 2-year study
- History of bone marrow transplantation, or autoimmune disease associated with
- Any medical condition that in the opinion of the principal investigator would
interfere with safe completion of the trial.
- Prior participation in a clinical trial that could potentially affect T1DM or
- Receipt of a live vaccine (e. g., varicella, measles, mumps, rubella, cold-attenuated
intranasal influenza vaccine, bacillus Calmette-GuÃ©rin, and smallpox) in the 6 weeks
- Participation in an investigational clinical trial within the last six weeks.
Locations and Contacts
Stephanie Meisner, RN, BSN, Phone: (404) 785-6453, Email: firstname.lastname@example.org
University of Arizona, Tuscon, Arizona 85724, United States; Recruiting
Doris Ross, Phone: 520-626-8112, Email: email@example.com
Kurt Griffin, MD, PhD, Principal Investigator
Children's Hospital of Los Angeles, Los Angeles, California 90027, United States; Recruiting
Meredith Bock, Phone: 323-361-6082, Email: firstname.lastname@example.org
Roshanek Monzavi, MD, Principal Investigator
University of California - San Francisco, San Francisco, California 94143, United States; Recruiting
Kathleen Fraser, Phone: 415-353-9084, Email: email@example.com
Stephen Gitelman, MD, Principal Investigator
Barbara Davis Center for Childhood Diabetes - University of Colorado, Aurora, Colorado 80045, United States; Recruiting
Rebecca Wagner, Phone: 303-724-7502, Email: Rebecca.Wagner@ucdenver.ed
Peter Gottlieb, MD, Principal Investigator
University of Miami Hospital and Clinics, Miami, Florida 33136, United States; Recruiting
Della Matheson, Phone: 305-243-3781, Email: firstname.lastname@example.org
Jennifer Marks, MD, Principal Investigator
Emory University, Atlanta, Georgia 30322, United States; Recruiting
Gregory Smallwood, Phone: 404-727-9831, Email: email@example.com
Stephanie Meisner, Phone: 404-785-6453, Email: firstname.lastname@example.org
Eric I Felner, MD, Principal Investigator
Sol Jacobs, MD, Sub-Investigator
Indiana University, Indianapolis, Indiana 46202, United States; Recruiting
LeeAnn Ford, Phone: 317-948-8879, Email: email@example.com
Stephanie Stein, Phone: 317-944-3889, Email: firstname.lastname@example.org
Linda DiMeglio, MD, MPH, Principal Investigator
Mark Rigby, MD, PhD, FAAP, FCCM, Principal Investigator
University of Iowa Hospital & Clinics, Iowa City, Iowa 52242, United States; Recruiting
Joanne Cabbage, Phone: 319-353-6070, Email: email@example.com
Sarah Salamati, Phone: 319-356-3954, Email: firstname.lastname@example.org
Eva Tsalikian, Principal Investigator
University of Maryland, Baltimore, Maryland 21201, United States; Recruiting
Debra Counts, MD, Phone: 410-328-3412, Email: email@example.com
Debra Counts, MD, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Sarah Dean, Phone: 617-643-6739, Email: firstname.lastname@example.org
Nicole A Sherry, MD, Principal Investigator
University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Carrie Gibson, Phone: 612-626-5206, Email: email@example.com
M. Anne Street, Phone: 612-625-9709, Email: firstname.lastname@example.org
Antoinette Moran, MD, Principal Investigator
Children's Mercy Hospitals and Clinics, Kansas City, Missouri 64108, United States; Recruiting
SueEllen Weigel, RN, Phone: 816-234-3975, Email: email@example.com
Wayne Moore, MD, Principal Investigator
Creighton University, Omaha, Nebraska 68131, United States; Recruiting
Kayla Zebrowski, Phone: 402-280-4319, Email: firstname.lastname@example.org
Shayla Addison, Phone: 402-280-4319, Email: email@example.com
Marc Rebdell, MD, Principal Investigator
University of Rochester Medical Center, Rochester, New York 14642, United States; Recruiting
Barbara Johnson, Phone: 585-276-3513, Email: firstname.lastname@example.org
Nicholas Jospe, MD, Principal Investigator
University of North Carolina, Durham, North Carolina 27713, United States; Recruiting
Gail Fuller, CCRC, Phone: 919-484-0931, Ext: 272, Email: email@example.com
Jean Dostou, MD, Principal Investigator
Michelle Duclos, MD, Sub-Investigator
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Tammy Calvano, Phone: 267-426-3908, Email: firstname.lastname@example.org
Olena Kucheruk, Phone: 267-426-3909, Email: email@example.com
Steven Willi, MD, Principal Investigator
Vanderbilt University, Nashville, Tennessee 37232, United States; Not yet recruiting
Faith Brendle, Phone: 615-936-8638, Email: firstname.lastname@example.org
Margo Black, Phone: 615-936-8638, Email: email@example.com
William Russell, MD, Principal Investigator
University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Renee Davis, BSN, RN, Phone: 214-648-8858, Email: firstname.lastname@example.org
Jamie Arthur, Phone: 214-648-4830, Email: email@example.com
Philip Raskin, MD, Principal Investigator
Benaroya Research Institute at Virginia Mason, Seattle, Washington 98101, United States; Recruiting
Christine Webber, Phone: 206-342-6936, Email: firstname.lastname@example.org
Diabetes Research Program, Phone: 800-888-4187, Email: email@example.com
Carla Greenbaum, MD, Principal Investigator
Starting date: March 2011
Last updated: November 16, 2011