Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

• INCLUSION CRITERIA:

  1. Recently diagnosed (within the preceding 4 months of screening) diabetes clinically consistent with T1D:

     A. Positive for anti-GAD antibody.

     B. BMI between 19 and 28 kg/m2; for those between the ages of 16 to 18, the BMI must be within 10th to 90th percentile for the age.

  2. Ages between 16 and 30 years, inclusive
  3. Random plasma C-peptide level of equal to or greater than 0.20 nmol/L
  4. Willingness and ability to institute intensive insulin-based glucose management.

EXCLUSION CRITERIA:

1. Diabetic nephropathy with a creatinine clearance less than 60 cc/min or 24 hour urine albumin greater than 300 mg
2. Insulin requirements greater than 0.8 units/kg/day at the end of the run-in period
3. Regular use of a proton pump inhibitor within 3 months of enrollment
4. Use of GLP-1R agonist or DPP-4 inhibitor within 6 months prior to enrollment
5. Use of immunosuppressive therapy in the preceding 12 months
6. Evidence of chronic infection, for example, known human immunodeficiency virus (HIV) or hepatitis
7. History of any malignancy other than a treated basal or squamous skin cancer
8. Any chronic medical condition to unduly increase risk for the potential enrollee as judged by study investigators
9. Pregnancy, breastfeeding or planned pregnancy within two years, women of reproductive age not using an effective mode of contraception and unwilling to continue adequate contraception until 1 year after the last study drug administration
10. Any other co-existing condition/circumstances that would make patient unsuitable to participate in the study, as deemed by the investigators. For example, study investigators would exclude any potential candidate with any of the following (but the list is not inclusive):

A. Clinically significant past history of an acute reaction to vaccines or other drugs

B. Recent participation in other clinical trials with a new chemical entity

C. A history of alcohol or drug abuse

D. Significant neurological conditions like epilepsy, head trauma, or cerebrovascular accidents

E. Individuals with significant gastrointestinal disorders determined by the study investigators to influence either study safety or data interpretation. Such conditions include but are not limited to gastroparesis and gastric bypass surgery

F. Individuals with conditions prone to hypergastrinemia (Zollinger-Ellison syndrome, use of histamine-2 receptor blockers) or hypogastrinemia (gastric surgery).