Status:
COMPLETED
Evaluation of TTP399 in Patients With Type 1 Diabetes
Lead Sponsor:
vTv Therapeutics
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ove...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2020
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03335371
Start Date
October 25 2017
End Date
January 6 2020
Last Update
July 3 2023
Active Locations (15)
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1
USC Westside Center for Diabetes
Beverly Hills, California, United States, 90211
2
AMCR Institute
Escondido, California, United States, 92025
3
University of Colorado Barbara Davis Center
Aurora, Colorado, United States, 80045
4
Atlanta Diabetes Associate
Atlanta, Georgia, United States, 30318