Ingested Interferon Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Type 1 Diabetes Mellitus
Ingested Interferon Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Type 1 Diabetes Mellitus
We hypothesize that ingested human recombinant interferon-alpha (hrIFN-a) will prolong the
 "honeymoon" period and enhance B cell survival in type 1 diabetes in a phase II randomized,
 placebo-controlled, double-blind clinical trial. We have demonstrated that ingested IFN-a
 prevents type 1 diabetes in the NOD mouse, prolongs the "honeymoon" period in newly diagnosed
 type 1 diabetics, and delays murine islet allograft rejection. The natural history of type 1
 diabetes is unique for a phase frequently referred as the "honeymoon," a period in which the
 insulin need becomes minimal and glycemic control improves. The B cell (the insulin producing
 cell) partially recovers. However, as with all honeymoons, they end and the patient becomes
 completely insulin-deficient. The general consensus of the international diabetes community
 is to test potential preventive therapies for type 1 diabetes in newly diagnosed patients.
 Prolongation of the honeymoon as the reversal of the disease is considered a positive result.

 In this phase II randomized, double-blind, parallel-design clinical trial we will determine
 whether ingested (oral) human recombinant IFN-a will prolong the "honeymoon" period and
 increase counterregulatory anti-inflammatory cytokine(s).

 We will determine the safety and efficacy of 30,000 units ingested hrIFN-a vs placebo in
 eighty patients with newly diagnosed type 1 diabetes in a phase II trial for one year.
 Primary outcome measures will be a 30% increase in C-peptide levels released after Sustacal
 stimulation at 3, 6, 9, and 12 months after entry. Secondary outcome will be decreasing
 titers of islet cell antibodies (ICA). If successful, a larger and longer phase III trial of
 prevention of type 1 diabetes in high risk patients will be undertaken. We will also
 determine if ingested hrIFN-a increases IL-4, IL-10 or IFN-a production in peripheral blood
 mononuclear cells (PMNC) from patients with recent onset type 1 diabetes.
Inclusion Criteria:

 -  Newly diagnosed type 1 diabetes (within one month of diagnosis).

 -  IDDM patients: Prepubescent, adolescent, or early adult patients.

 Exclusion Criteria:

 -  Patients below the age of 3 or over 25.

 -  Patients will not be eligible if they are on immunosuppressive or immunostimulatory
 medications such as azathioprine, oral nicotinamide, superoxide
 dismutase-desferroxamine, vitamin E, aminoguanidine, oral insulin or other
 experimental therapies at any time.

 -  Patients with a history of alcoholism, renal, cardiac, or pulmonary disease or in whom
 intellectual functioning is impaired sufficiently to interfere with the understanding
 of the protocol, or participation in the treatment and evaluation program

 -  Patients who are pregnant or nursing, or those who are not willing to practice an
 acceptable birth control method

 -  Patients with abnormal pre-treatment values on WBC or who are receiving potentially
 hepatotoxic medications