CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 115 enrolled
Drug / intervention
TTP399 +2 moredrug
Likely dose
TTP399 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03335371
NCT03335371Phase 2Completed
CompareCT.gov

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

vTv Therapeutics·interventional·Posted Nov 7, 2017·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating TTP399 and Placebo Oral Tablet for Diabetes Mellitus, Type 1. Completed, enrolled 115 participants across 15 sites.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 7, 2017
Enrollment StartOct 25, 2017
Primary CompletionDec 20, 2019
Study CompletionJan 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.7 years ago

Interventions

TTP399drug

Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days

TTP399drug

Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks

Placebo Oral Tabletdrug

Phase 2: Participants will receive Placebo oral tablets for 12 weeks