Evaluation of TTP399 in Patients With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03335371
- Lead Sponsor
- vTv Therapeutics
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TTP399 400 mg TTP399 - Placebo Placebo Oral Tablet -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 Baseline (Day 1) to Week 13 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.
Sentinel - Area Under the Concentration Time Curve (AUC) Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing. AUC for Day 1 per dose level (400 mg, 800 mg, and 1200 mg) is AUC from 0 to 9 hours.
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 Outcome Measures
Name Time Method Percent Change From Baseline Time in Target Glycemic Range (70-180 mg/dL) Baseline (Day 1) to Week 12 To evaluate the change from baseline time in target range (24 hour)
Percent Change From Baseline Time in Hypoglycemia (< 54 mg/dL) Baseline (Day 1) to Week 12 To evaluate the change from baseline time in hypoglycemia (\< 54 mg/dL)
Percent Change From Baseline Time in Hypoglycemia (< 70 mg/dL) Baseline (Day 1) to Week 12 To evaluate the change from baseline time in hypoglycemia (\< 70 mg/dL)
Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL) Baseline (Day 1) to Week 12 To evaluate the change from baseline time in hypoglycemia (\>180 mg/dL)
Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL) Baseline (Day 1) to Week 12 To evaluate the change from baseline time in hypoglycemia (\>250 mg/dL)
Percent Change From Baseline in Total Daily Insulin Use Baseline (Day 1) to Week 12 To evaluate the percent change from baseline in total daily insulin use at week 12.
Change From Baseline in Bolus Insulin Use Baseline (Day 1) to Week 12 To evaluate the change from baseline in bolus insulin use
Change From Baseline in Basal Insulin Use Baseline (Day 1) to Week 12 To evaluate the change from baseline in basal insulin use
Trial Locations
- Locations (15)
AMCR Institute
🇺🇸Escondido, California, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
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
Duke University Diabetes Research Clinic
🇺🇸Durham, North Carolina, United States
Intend Research
🇺🇸Norman, Oklahoma, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
University of Washington Medicine Diabetes Institute
🇺🇸Seattle, Washington, United States
USC Westside Center for Diabetes
🇺🇸Beverly Hills, California, United States
Iowa Diabetes Research
🇺🇸West Des Moines, Iowa, United States
Mountain Diabetes and Endocrine Center
🇺🇸Asheville, North Carolina, United States
Diabetes & Endocrinology Consultants
🇺🇸Morehead City, North Carolina, United States
UNC Diabetes Care Center
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States