The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes (IIT)
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Insulin Independence, Beta Regeneration, Immune Tolerance Agent, Lanzoprazole, Cyclosporine
Eligibility Criteria
Inclusion Criteria:
- They are male or female, 8-60 years of age
They have a history of onset of type 1 Diabetes Mellitus at or before 20 years of age; or have documentation of autoimmunity testing to the pancreas to include one of more of the following tests
- Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
- Glutamic Acid Decarboxylase (GAD) autoantibodies, or
- Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive)
- They have a C-peptide of greater than or equal to to 0.6 ng/mL (0.2 nmol/L)
- They have a Hemoglobin A1C levels of less than 9%
- They are able and willing to participate in the study, as evidenced by providing written informed consent
- Females must be post-menopausal (at least 1 year without spontaneous menses) or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or to have a negative pregnancy test and practice acceptable contraception [e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine device]. Females of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of study drug.
Exclusion Criteria:
- Prior administration of immune tolerance therapy or immune tolerance clinical trial for type 1 diabetes
- Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
- Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
- Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
- Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
- Current treatment with oral antidiabetic agents
- Evidence of active or latent tuberculosis
Vaccination with a live virus or organism within the 8 weeks before randomization continuing through week 52 of the study
- Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle
- Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle
- Systolic or diastolic blood pressure >150 mmHg and 90 mmHg, respectively, as measured by an appropriately sized cuff;
- A body mass index (BMI) >28 kg/m2
- Worsening retinopathy, angina, or congestive heart failure
- A history or presence of acute or chronic pancreatitis
- A history or presence of any illness, disease, or condition that could impact patient safety or evaluability of drug effect, in the Investigator's opinion
- An episode of severe hypoglycemia (defined as a change in mental status requiring assistance) during the prior 30 days
- An episode of diabetic ketoacidosis during the prior 6 months
- Received any new hypoglycemic medications within the past 3 months
- An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level >2 times the upper limit of normal (ULN)
- A blood urea nitrogen (BUN) level >50 mg/dL or a serum creatinine level >1.4 mg/dL
- A serum amylase level >1.5 times the ULN or a serum lipase level >2 times the ULN
- A history of substance abuse or dependence in the past year as defined by the Diagnostic and Statistical Manual of Mental Disorders, (DSM V) criteria
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Oral CyclosporineA and Oral Lansoprazole
Placebos
Oral Cyclosporine A dosed at 7.5 mg/kg/day in two divided dosages given with Lansoprazole dosed at 30 mg per day in two divided dosages for subjects aged 8-15 year and 60 mg per day for those aged 16-60.