Evaluation of TTP399 in Patients With Type 1 Diabetes

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT03335371

Run by

vTv Therapeutics

People needed

115

Starts

2017-10-25

Expected to finish

2020-01-06

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• USC Westside Center for Diabetes — Beverly Hills, California, United States
• AMCR Institute — Escondido, California, United States
• University of Colorado Barbara Davis Center — Aurora, Colorado, United States
• Atlanta Diabetes Associate — Atlanta, Georgia, United States
• Rocky Mountain Diabetes Center — Idaho Falls, Idaho, United States
• Iowa Diabetes Research — West Des Moines, Iowa, United States
• Mountain Diabetes and Endocrine Center — Asheville, North Carolina, United States
• UNC Diabetes Care Center — Chapel Hill, North Carolina, United States
• Duke University Diabetes Research Clinic — Durham, North Carolina, United States
• Diabetes & Endocrinology Consultants — Morehead City, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Wake Forest — Winston-Salem, North Carolina, United States
• Intend Research — Norman, Oklahoma, United States
• Dallas Diabetes Research Center — Dallas, Texas, United States
• University of Washington Medicine Diabetes Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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