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Inducing Remission in Type 1 Diabetes With Alefacept

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: New-onset Type 1 Diabetes Mellitus

Intervention: Alefacept (Biological); Placebo (Drug)

Phase: Phase 2

Status: Completed

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: Indiana University


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 is a multi-center prospective, placebo-controlled, double-blind and randomized trial to investigate the ability of alefacept to protect residual beta cells from ongoing autoimmune destruction in adolescents and young adults with newly diagnosed Type 1 Diabetes Mellitus (T1DM).

Clinical Details

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: 2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)

Secondary outcome:

4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)

2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)

Insulin Use in Units Per Kilogram Body Weight Per Day

Major Hypoglycemic Events Occurring From Randomization

Hemoglobin A1c

Detailed description: T1DM is an autoimmune disease that can emerge suddenly, causing dependence on insulin for life. This means that the 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, one's ability to produce insulin is decreased. Insulin helps keep blood glucose (sugar) levels normal. For a period right after diagnosis, the pancreas is still able to make small amounts of insulin. Individuals 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. Research has improved the outlook for T1DM over the last decade. Doctors are investigating, for example, how to save insulin-producing cells and extend the honeymoon period as long as possible. Despite progress towards understanding the science behind T1DM, there remains a significant need to investigate alternative approaches to this disease in order to bring about long-term remission. For this reason, scientists are working hard to develop new treatments that can be given soon after diagnosis to preserve the remaining beta cells. Currently there is no cure for T1DM; however, with new investigational medications and innovative clinical research studies, such as T1DAL, a new approach towards managing T1DM 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 treatment intervals. 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. Gender(s): Both.


Inclusion Criteria:

- Recent diagnosis (within 100 days of enrollment) of T1DM

- 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) Exclusion Criteria:

- 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

opportunistic infections

- Evidence of infection with hepatitis B virus (HBV) as defined by hepatitis B surface

antigen, HBsAg; hepatitis C virus (HCV) defined by anti-HCV antibodies; human immunodeficiency virus (HIV); or toxoplasmosis

- Positive tuberculin skin test (PPD)

- Clinically active infection with Epstein-Barr virus (EBV)-EBV viral load ≥ 10,000

copies per 10^6 PBMCs; cytomegalovirus (CMV) - CMV viral load ≥10,000 copies per mL

whole blood; or tuberculosis (TB)

- Diagnosis of liver disease or hepatic enzymes, as defined by ALT and/or AST ≥ 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, β-adrenergic blockers, niacin)

- Any of the following hematologic abnormalities, confirmed by repeat tests at least 1

week apart: 1. White blood count <4000/μL or >14,000/μL; 2. CD4+ count below the lower limit of normal; 3. Platelet count <150,000 /μL; 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

immunologic status

- Receipt of a live vaccine (e. g., varicella, measles, mumps, rubella, cold-attenuated

intranasal influenza vaccine, bacillus Calmette-Guérin, and smallpox) in the 6 weeks before enrollment

- Participation in an investigational clinical trial within the last six weeks

Locations and Contacts

University of Arizona, Tuscon, Arizona 85724, United States

Children's Hospital of Los Angeles, Los Angeles, California 90027, United States

University of California - San Francisco, San Francisco, California 94143, United States

Barbara Davis Center for Childhood Diabetes - University of Colorado, Aurora, Colorado 80045, United States

Emory University, Atlanta, Georgia 30322, United States

Indiana University, Indianapolis, Indiana 46202, United States

University of Iowa Hospital & Clinics, Iowa City, Iowa 52242, United States

University of Maryland, Baltimore, Maryland 21201, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Children's Mercy Hospitals and Clinics, Kansas City, Missouri 64108, United States

Creighton University, Omaha, Nebraska 68131, United States

University of North Carolina, Durham, North Carolina 27713, United States

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

Benaroya Research Institute at Virginia Mason, Seattle, Washington 98101, United States

Additional Information

National Institute of Allergy and Infectious Diseases (NIAID) website

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) website

Immune Tolerance Network (ITN) website

Juvenile Diabetes Research Foundation (JDRF) website

Related publications:

Herold KC. Restoring immune balance in type 1 diabetes. Lancet Diabetes Endocrinol. 2013 Dec;1(4):261-3. doi: 10.1016/S2213-8587(13)70123-2. Epub 2013 Sep 23.

Starting date: March 2011
Last updated: January 6, 2015

Page last updated: August 20, 2015

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