Interferon-Alpha for Diabetes Mellitus Type 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00024518
First received: September 19, 2001
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

This study will see if interferon-alpha given early in the disease can stop or slow the immune attack on insulin-producing cells. In addition, the study will examine the safety and efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between 3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for this study. All study-related tests and medications at the NIH Clinical Center are provided at no cost.


Condition Intervention Phase
Insulin-Dependent Diabetes Mellitus
Drug: 30,000 units hrINF-alpha
Drug: 5,000 hrINF-alpha
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ingested Interferon-Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • C-Peptide Level [ Time Frame: Baseline - 3mth, 6mnth, 9mnth, 12mnth ] [ Designated as safety issue: No ]
    The Connecting Peptide, or C-peptide, is a short 31-amino-acid protein that connects insulin's A-chain to its B-chain in the proinsulin molecule.


Secondary Outcome Measures:
  • Serum glucose [ Time Frame: baseline - 3mths, 6mnths, 9mnths, 12mnths ] [ Designated as safety issue: No ]
    Serum glucose or blood sugar measurements determine how much sugar is in the blood.

  • Hemoglobin A1C [ Time Frame: Baseline - 3mnths, 6mnths, 9mnths, 12mnths ] [ Designated as safety issue: No ]
    a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.


Enrollment: 57
Study Start Date: September 2001
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo was prepared as saline alone with 6mg human serum albumin (HSA). Subjects orally ingested one vial each morning before breakfast with at least 150mL water.
Other: Placebo
placebo was prepared as saline alone with 6mg human serum albumin (HSA).
Experimental: 5,000 Units hrIFN-alpha
hrIFN-alpha = human recombinant interferon-alpha. 5,000 units was prepared along with saline and 6mg HSA. Subjects orally ingested one vial each morning before breakfast with at least 150mL water.
Drug: 5,000 hrINF-alpha
Other Name: Human Recombinant Interferon-alpha
Experimental: 30,000 hrIFN-alpha
30,000 units hrIFN-alpha was prepared along with saline and 6mg HSA. Subjects orally ingested one vial each morning before breakfast with at least 150mL water.
Drug: 30,000 units hrINF-alpha
N/A
Other Name: Human Recombinant Interferon-alpha

Detailed Description:

Type 1 diabetes mellitus (T1DM) results from autoimmune destruction of the insulin-producing pancreatic beta-cells. The onset of clinical symptoms represents the endpoint of a chronic progressive decline in beta-cell function when the number of functional beta-cells descends below the critical mass required for maintenance of euglycemia ([1], [2]). However, the pancreas still retains the ability to produce a substantial amount of insulin. The goal of secondary prevention in T1DM is to avert further destruction of the remaining beta-cells and therefore delay or stop entry into the final stages of the disease associated with end organ damage.

The rationale for this study is to interfere with the autoimmune beta-cell destruction early on in order to preserve as much residual endogenous insulin production as possible. We plan to administer oral interferon-alpha (IFN-a) on a daily basis, which has been shown to modify the clinical course of diabetes, to alter cytokine release, and reduce expression of T cell activation markers in an animal model ([3]) and a pilot project in humans (S. Brod, University of Texas, unpublished data). The one-year study is designed as a double blind randomized protocol using either 5,000 or 30,000 units of IFN-a versus placebo. Five centers will participate in this protocol (University of Texas Health Science Center in Houston; Dallas; Children's Hospital, St. Paul, MN; Kansas City and NIH, Bethesda, Maryland).

  Eligibility

Ages Eligible for Study:   3 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

T1DM of less than 6 weeks duration in patients between 3 and 25 years of age.

Besides T1DM, no concurrent illness.

EXCLUSION CRITERIA:

Treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.

Abnormal pre-treatment white blood cell count (WBC) or thrombocytopenia.

Known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.

History of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.

Ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.

Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Inability to give informed consent or assent.

Participation in a clinical trial within the previous 6 weeks.

Lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).

Age above 25 years, since there may be several subtypes of T1DM.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024518

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Minnesota
Children's Hospital - St. Paul
St. Paul, Minnesota, United States
United States, Missouri
Children's Hospital - Kansas City
Kansas City, Missouri, United States
United States, Texas
University of Texas, Dallas
Dallas, Texas, United States, 75216
University of Texas, Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Kristina I Rother, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Staley A Brod, MD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
Publications:
Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00024518     History of Changes
Other Study ID Numbers: 010249, 01-DK-0249
Study First Received: September 19, 2001
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center, Houston:
Diabetes
Immunotherapy
Study Drug
Insulin Dependent Diabetes
Diabetes Mellitus
TIBM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014