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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
115
USC Westside Center for Diabetes
Beverly Hills, California, United States
AMCR Institute
Escondido, California, United States
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.
Time frame: 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.
Time frame: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Sentinel - Maximum Drug Concentration (Cmax)
Time frame: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Sentinel - Time to Maximum Concentration (Tmax)
Time frame: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (Day 1) to Week 12
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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
...and 5 more locations
Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL)
To evaluate the change from baseline time in hypoglycemia (\>180 mg/dL)
Time frame: 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)
Time frame: 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.
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Bolus Insulin Use
To evaluate the change from baseline in bolus insulin use
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Basal Insulin Use
To evaluate the change from baseline in basal insulin use
Time frame: Baseline (Day 1) to Week 12