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NCT03335371 · ClinicalTrials.gov registry record · Phase 1
Evaluation of TTP399 in Patients With Type 1 Diabetes
A Phase 1 study of Diabetes Mellitus, Type 1, sponsored by vTv Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
- 15
- Study locations
NCT03335371: Completed Phase 1 study of Diabetes Mellitus, Type 1, sponsored by vTv Therapeutics.
NCT03335371 is a Phase 1 study of Diabetes Mellitus, Type 1 that has completed, run by vTv Therapeutics. The registered enrollment target is 115 participants, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (91% lower). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03335371, a Phase 1 study of Diabetes Mellitus, Type 1, has completed, sponsored by vTv Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
To evaluate the change in glycosylated hemoglobin (HbA1C) in Part 1 and Part 2 participants following multiple-day dosing (at 12 weeks) in subjects with T1MD. Sentinel participants were not evaluated for a change in HbA1C.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG TTP399
Study Locations (15)
North Carolina
- Mountain Diabetes and Endocrine Center - Asheville
- UNC Diabetes Care Center - Chapel Hill
- Duke University Diabetes Research Clinic - Durham
- Diabetes & Endocrinology Consultants - Morehead City
- PMG Research of Wilmington - Wilmington
- Wake Forest - Winston-Salem
California
- USC Westside Center for Diabetes - Beverly Hills
- AMCR Institute - Escondido
Colorado
- University of Colorado Barbara Davis Center - Aurora
Georgia
- Atlanta Diabetes Associate - Atlanta
Idaho
- Rocky Mountain Diabetes Center - Idaho Falls
Iowa
- Iowa Diabetes Research - West Des Moines
Oklahoma
- Intend Research - Norman
Texas
- Dallas Diabetes Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2017-10-25 |
| Est. Completion | 2020-01-06 |
| Phase | Phase 1 |
What the finished NCT03335371 record still lists
NCT03335371 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03335371 lists 15 locations in 9 states (North Carolina, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03335371 about?
NCT03335371 is a clinical study titled "Evaluation of TTP399 in Patients With Type 1 Diabetes". 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 o...
What is the current status of trial NCT03335371?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2017-10-25. Estimated completion is 2020-01-06.
What conditions does trial NCT03335371 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT03335371?
The interventions under investigation include: Placebo Oral Tablet (DRUG), TTP399 (DRUG).
Who is sponsoring clinical trial NCT03335371?
This trial is sponsored by vTv Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03335371 being conducted?
This trial has 15 study locations across California, Colorado, Georgia, Idaho, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03335371's enrollment target sits among peer trials
115 47th of 118 higher than 72 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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