Diabetes Mellitus, Type 1 Clinical Trial
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Terminated |
NCT03605329 -
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
|
N/A | |
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Recruiting |
NCT06050642 -
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
|
N/A | |
| Completed |
NCT05107544 -
Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT04443153 -
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
|
N/A | |
| Completed |
NCT04569994 -
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
|
Phase 1 | |
| Completed |
NCT04521634 -
Glycaemic Variability in Acute Stroke
|
||
| Completed |
NCT04089462 -
Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
|
N/A | |
| Completed |
NCT03143816 -
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
|
Phase 4 | |
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
| Completed |
NCT04042207 -
Diabeloop for Highly Unstable Type 1 Diabetes
|
N/A | |
| Not yet recruiting |
NCT06068205 -
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
|
||
| Recruiting |
NCT05909800 -
Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.
|
Phase 2 | |
| Active, not recruiting |
NCT04974528 -
Afrezza® INHALE-1 Study in Pediatrics
|
Phase 3 | |
| Completed |
NCT04530292 -
Home Intervention and Social Precariousness in Childhood Diabetes
|
N/A | |
| Completed |
NCT05428943 -
OPT101 in Type 1 Diabetes Patients
|
Phase 1 | |
| Recruiting |
NCT03988764 -
Monogenic Diabetes Misdiagnosed as Type 1
|
||
| Completed |
NCT05597605 -
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
|
N/A |