Interferon-Alpha for Diabetes Mellitus Type 1
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| ClinicalTrials.gov Identifier: NCT00024518 |
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Recruitment Status :
Completed
First Posted : September 19, 2001
Last Update Posted : November 19, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Insulin-Dependent Diabetes Mellitus | Drug: 30,000 units hrINF-alpha Drug: 5,000 hrINF-alpha Other: Placebo | Phase 2 |
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of T cell activation markers in an animal model ([3]) and a pilot project in humans (S. Brod, University of Texas, unpublished data).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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 57 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Ingested Interferon-Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Diabetes Mellitus |
| Study Start Date : | September 2001 |
| Actual Primary Completion Date : | September 2008 |
| Actual Study Completion Date : | September 2008 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: Placebo
placebo was prepared as saline alone with 6mg human serum albumin (HSA). |
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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.
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Drug: 5,000 hrINF-alpha
Other Name: Human Recombinant Interferon-alpha |
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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.
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Drug: 30,000 units hrINF-alpha
Other Name: Human Recombinant Interferon-alpha |
- C-Peptide Level [ Time Frame: Baseline - 3mth, 6mnth, 9mnth, 12mnth ]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.
- Serum glucose [ Time Frame: baseline - 3mths, 6mnths, 9mnths, 12mnths ]Serum glucose or blood sugar measurements determine how much sugar is in the blood.
- Hemoglobin A1C [ Time Frame: Baseline - 3mnths, 6mnths, 9mnths, 12mnths ]a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
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| Ages Eligible for Study: | 3 Years to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024518
| 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 | |
| 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 |
Additional Information:
Publications of Results:
Other 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 |
| First Posted: | September 19, 2001 Key Record Dates |
| Last Update Posted: | November 19, 2013 |
| Last Verified: | November 2013 |
|
Diabetes Immunotherapy Study Drug |
Insulin Dependent Diabetes Diabetes Mellitus TIBM |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Interferons |
Interferon-alpha Interferon alpha-2 Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |