| Trial ID: | L6542 |
| Source ID: | NCT03335371
|
| Associated Drug: |
Ttp399
|
| Title: |
Evaluation of TTP399 in Patients With Type 1 Diabetes
|
| Acronym: |
SimpliciT1
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03335371/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: TTP399|DRUG: TTP399|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12, 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., Baseline (Day 1) to Week 13|Sentinel - Area Under the Concentration Time Curve (AUC), AUC for Day 1 per dose level (400 mg, 800 mg, and 1200 mg) is AUC from 0 to 9 hours., Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.|Sentinel - Maximum Drug Concentration (Cmax), Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.|Sentinel - Time to Maximum Concentration (Tmax), Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing. | Secondary: Percent Change From Baseline Time in Target Glycemic Range (70-180 mg/dL), To evaluate the change from baseline time in target range (24 hour), Baseline (Day 1) to Week 12|Percent Change From Baseline Time in Hypoglycemia (< 54 mg/dL), To evaluate the change from baseline time in hypoglycemia (\< 54 mg/dL), Baseline (Day 1) to Week 12|Percent Change From Baseline Time in Hypoglycemia (< 70 mg/dL), To evaluate the change from baseline time in hypoglycemia (\< 70 mg/dL), Baseline (Day 1) to Week 12|Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL), To evaluate the change from baseline time in hypoglycemia (\>180 mg/dL), Baseline (Day 1) to Week 12|Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL), To evaluate the change from baseline time in hypoglycemia (\>250 mg/dL), Baseline (Day 1) to Week 12|Percent Change From Baseline in Total Daily Insulin Use, To evaluate the percent change from baseline in total daily insulin use at week 12., Baseline (Day 1) to Week 12|Change From Baseline in Bolus Insulin Use, To evaluate the change from baseline in bolus insulin use, Baseline (Day 1) to Week 12|Change From Baseline in Basal Insulin Use, To evaluate the change from baseline in basal insulin use, Baseline (Day 1) to Week 12
|
| Sponsor/Collaborators: |
Sponsor: vTv Therapeutics | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
115
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-10-25
|
| Completion Date: |
2020-01-06
|
| Results First Posted: |
2023-07-03
|
| Last Update Posted: |
2023-07-03
|
| Locations: |
USC Westside Center for Diabetes, Beverly Hills, California, 90211, United States|AMCR Institute, Escondido, California, 92025, United States|University of Colorado Barbara Davis Center, Aurora, Colorado, 80045, United States|Atlanta Diabetes Associate, Atlanta, Georgia, 30318, United States|Rocky Mountain Diabetes Center, Idaho Falls, Idaho, 83404, United States|Iowa Diabetes Research, West Des Moines, Iowa, 50265, United States|Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States|UNC Diabetes Care Center, Chapel Hill, North Carolina, 27517, United States|Duke University Diabetes Research Clinic, Durham, North Carolina, 27710, United States|Diabetes & Endocrinology Consultants, Morehead City, North Carolina, 28557, United States|PMG Research of Wilmington, Wilmington, North Carolina, 28401, United States|Wake Forest, Winston-Salem, North Carolina, 27104, United States|Intend Research, Norman, Oklahoma, 73069, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|University of Washington Medicine Diabetes Institute, Seattle, Washington, 98109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03335371
|
