Evaluation of TTP399 in Patients With Type 1 Diabetes

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose, Adaptive Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of TTP399 in With Adult Patients Type 1 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of TTP399 in Type 1 diabetics. This study will be in 2 phases: phase 1 will evaluate the safety of different TTP399 dosage regimens over 1 week of daily dosing. Phase 2 will evaluate the safety and efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.

Inclusion Criteria:

• People diagnosed with T1DM, confirmed diagnosis prior to 40 years of age and a diagnosed for minimum of 1 year.
• Type 1 diabetics using either continuous subcutaneous insulin infusion (with lispro or aspart) or multiple daily doses of insulin
• Willing to use adequate contraception
• No major surgeries or significant injuries within the past year and without an active infection.

Exclusion Criteria:

• Diagnosis of T2DM, severely uncontrolled T1DM, maturity-onset diabetes of the young, insulin-requiring T2DM, other unusual or rare forms of diabetes mellitus, diabetes resulting from a secondary disease
• Receipt of an investigational product within 30 days of the Screening Visit or any therapeutic protein or antibody within 90 days prior to Screening Visit or any previous treatment with TTP399.
• Living in the same household or related to another participant in this study.
• Two severe episodes of hypoglycemia that required assistance by a third party within 3 months of Screening Visit
• Use of antidiabetic medications other than insulin 3 months prior to Screening Visit, systemic corticosteroids 1 month prior to Screening Visit, weight loss medication 2 weeks prior to Screening Visit, and antipsychotic medications 3 months prior to Screening Visit.
• Participation in any formal weight loss program or contemplating such therapy during the trial.
• Recent history of use of non-prescribed controlled substances or illicit drugs.
• Current alcoholism or a history of excessive alcohol consumption within 2 years prior to screening
• History or presence of symptomatic autonomic neuropathy or chronic gastrointestinal disease.
• Personal history of long QT syndrome.
• Blood donation of approximately 1 pint (500 mL) within 8 weeks before Screening Visit
• History of hemolytic anemia or chronic transfusion requirement.
• History of cancer, other than non-melanoma skin cancer or uterine cervical cancer that required therapy in the past 5 years.
• Breastfeeding