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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 15
- 主要终点
- Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 TTP
- •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
研究组 & 干预措施
TTP399 400 mg
干预措施: TTP399 (Drug)
Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
时间窗: 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)
时间窗: 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)
时间窗: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Sentinel - Time to Maximum Concentration (Tmax)
时间窗: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
次要结局
- Percent Change From Baseline Time in Target Glycemic Range (70-180 mg/dL)(Baseline (Day 1) to Week 12)
- Percent 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)(Baseline (Day 1) to Week 12)
- Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL)(Baseline (Day 1) to Week 12)
- Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL)(Baseline (Day 1) to Week 12)
- Percent Change From Baseline in Total Daily Insulin Use(Baseline (Day 1) to Week 12)
- Change From Baseline in Bolus Insulin Use(Baseline (Day 1) to Week 12)
- Change From Baseline in Basal Insulin Use(Baseline (Day 1) to Week 12)