Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring T1DM, Regeneration, Islet, Beta cell, INGAP Peptide Read More

Inclusion Criteria:

Patients meeting all of the following criteria will be eligible for enrollment in the study:

• Male and female patients between the ages of 19 and 60 years old, inclusive, with a history of T1DM for >2 years and ≤40 years;
• Receiving multiple daily insulin injections or insulin pump therapy for >2 years;
• Body mass index (BMI) ≤32 kg/m2;
• HbA1c ≤7.7%;
• Fasting C-peptide levels <0.6 ng/mL
• Willing to sign the study informed consent document;
• In good general health with no late severe complications or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor;
• If treated with angiotensin-converting enzymes/angiotensin II receptor blockers (ACE/ARB), the doses should be unchanged for a month prior to enrollment; and

• Females of child bearing potential must have a negative urine pregnancy test on Day 0 prior to dispensing drug and should additionally fulfill one of the following criteria:

  • Willing to use oral, implantable, transdermal, or injectable contraceptives for 21 days prior to the first dose and until 28 days after the last dose; or,
  • Willing to use another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by sexual partner, or a sterile sexual partner) from Screening until after the last blood sample (at Week 16).

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from study participation:

• • Total daily insulin dosage exceeding 1.0 U/kg/day or a change in total daily insulin dose level of more than 50% (increase or decrease) within the past 3 months;
• Treatment with any diabetes medication other than insulin;
• A score of 4 or more restricted responses on the Clarke Hypoglycemia Awareness Survey;
• Systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively;
• Clinical worsening of retinopathy or neuropathy in the previous 3 months;
• Clinical worsening of nephropathy in the previous 3 months, or blood urea nitrogen (BUN) and serum creatinine exceeding 50 mg/dL and 2.0 mg/dL, respectively;
• History or presence of acute or chronic pancreatitis, including a serum amylase level >1.5 times the upper limit of normal (ULN) or a serum lipase level >2 times ULN;
• 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 (change in mental status requiring assistance) during the previous 30 days;
• An episode of acute glycemic decompensation with associated hyperosmolar non-ketotic state or diabetic ketoacidosis during the past 6 months;
• A serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin level >2 times ULN;
• Received any investigational product within 30 days of admission into this study or had any prior or existing exposure to INGAP Peptide or glucagon-like peptides (GLP 1, GLP 2, or analogs);
• Concurrent or planned participation in any other clinical study during the conduct of this study;
• Positive urine test for cocaine, opiates, amphetamines, or cannabinoids;
• Inability to fill out and maintain a daily diary during the screening period prior to dosing; or,
• Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C seropositivity in blood sample taken during screening.