NCT02405260已完成2 期
A Multi-Center, Adaptive Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled (Sitagliptin), Parallel Group Study to Evaluate the Safety and Efficacy of TTP399 Following 6 Months Administration in Subjects With Type 2 Diabetes Mellitus on A Stable Dose of Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 主要终点
- Change in HbA1c (Glycosylated haemoglobin)
研究概览
简要总结
This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active- controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of TTP399 on HbA1c following administration for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A historical diagnosis of Type 2 Diabetes in accordance with the American Diabetes Association (ADA) guidelines, with diagnosis at least 6 months prior to Screening.
- •On a stable (for the last 3 months prior to screening) regimen of metformin monotherapy equivalent of at least 1000 mg once daily.
- •Males, females of childbearing potential (must have a negative pregnancy test and be willing to comply with protocol contraception), and females of non-childbearing potential.
- •Age 18 to 75 years, inclusive, at the time of screening.
- •HbA1c ≥7.0% and ≤9.5%.
- •Generally stable health without active infection or history of major surgery or significant injuries within the last year.
排除标准
- •Diagnosis of Type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring Type 2 Diabetes, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis.
- •Clinically significant abnormal lab values including eGFR <50ml/min/1.73m2, ALT, bilirubin or AST >1.5 X ULN, hypokalemia or other clinically significant electrolyte abnormality.
- •History of myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack within 2 years of screening.
- •Presence of symptomatic congestive heart failure.
- •History of cardiac arrhythmias requiring treatment or prophylaxis with drugs or devices during the last 2 years or any history of atrial fibrillation or flutter beyond a single short-term episode (e.g., lasting 1-2 days).
- •History or presence of a 2nd degree or greater atrioventricular block in the absence of a pacemaker.
- •A 12-lead ECG, from screening or baseline demonstrating QTcF interval >450 msec for males or >47 msec for females.
- •A family or personal history of long QT syndrome.
- •History of pancreatitis.
- •Persistent, uncontrolled hypertension.
- •Presence of chronic active hepatitis (hepatitis B, hepatitis C, nonalcoholic steatohepatitis [NASH]) and/or known liver cirrhosis.
- •Participation in any formal weight loss program, or fluctuation of > 5% in body weight, or having received medications approved for weight loss within 3 months prior to screening.
- •A positive pre-study drug screen.
- •Participation in a clinical trial and receipt of an investigational product within 30 days.
- •Have a history of drug abuse within 2 years of screening or a positive pre-screen drug screen.
- •Have a history of hypoglycemic episode requiring glucose, glucagon, or orange juice administered by someone other than the patient within 6 months prior to screening.
- •A history of excessive alcohol consumption within the last 2 years prior to screening
- •Mental or legal incapacitation.
- •Blood donation of approximately 1 pint (500 mL) within 8 weeks.
- •History of MEN-2 or family history of medullary thyroid cancer.
- •History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior study start.
研究组 & 干预措施
TTP399 400 mg
Experimental
TTP399 once daily
干预措施: TTP399 400 mg (Drug)
TTP399 800 mg
Experimental
TTP399 once daily
干预措施: TTP399 800 mg (Drug)
Sitagliptin 100 mg
Active Comparator
Sitagliptin once daily
干预措施: Sitagliptin 100 mg (Drug)
Placebo
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated haemoglobin)
时间窗: Day 1 to Day 168
次要结局
- Urinalysis(Day 1 to Day 182)
- Pulse(Day 1 to Day 182)
- HbA1c < 7% at 6 months(Day 1 to Day 168)
- HbA1c < 6.5% at 6 months(Day 1 to Day 168)
- Plasma Glucose Levels(Day 1 to Day 168)
- Lipid Levels(Day 1 to Day 168)
- Insulin Levels(Day 1 to Day 168)
- Lactate Levels(Day 1 to Day 168)
- C-peptide Levels(Day 1 to Day 168)
- Glucagon Levels(Day 1 to Day 168)
- Glucagon-like Peptide-1 Levels(Day 1 to Day 168)
- Change in Body Weight(Day 1 to Day 168)
- Adverse Events(Day 1 to Day 182)
- Blood Pressure(Day 1 to Day 182)
- Electrocardiogram Parameters(Day 1 to Day 182)
- Hematology(Day 1 to Day 182)
- Blood Chemistry(Day 1 to Day 182)
研究者
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