Evaluation of TTP399 in Patients With Type 1 Diabetes

Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - 70
Start Date:October 25, 2017
End Date:December 2019
Contact:Jennifer Freeman, Ph.D.
Phone:(336) 841-0300

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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

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 (including
previous treatment with TTP399) or any therapeutic protein or antibody within 90 days
prior to Screening Visit.

- Living in the same household or related to another participant in this study.

- Hypoglycemia unawareness

- 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

- 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
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