NCT02653599已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Multi-Center Study to Evaluate the Efficacy and Safety of TTP273 Following 12 Weeks 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
- 174
- 主要终点
- Change in HbA1c from baseline at 12 weeks
研究概览
简要总结
This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group, Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight following administration for 3 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
- •The subject has a 6 month diagnosis of Type 2 diabetes mellitus prior to screening and meets the American Diabetes Association (ADA) guidelines for Type 2 diabetes mellitus.
- •On a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for the last 3 months prior to screening.
- •Males. Females of non-childbearing potential.
- •Generally stable health without a history of major surgery or significant injuries within the last year and without an active infection.
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.
- •Participation in a clinical trial and receipt of an investigational product within 30 days.
- •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 or contemplating such therapy during the trial.
- •Previous surgical treatment of obesity.
- •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.
- •Use of other diabetic agents except metformin within 3 months prior to Screening.
- •History of pancreatitis.
- •Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to screening.
- •History of hemolytic anemia, chronic transfusion requirement or other condition rendering HbA1c results unreliable.
- •History of MEN-2 or family history of medullary thyroid cancer.
- •History or presence of clinically significant disease (other than Type 2 diabetes mellitus).
研究组 & 干预措施
TTP273 300 mg daily (150 mg BID)
Experimental
Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks
干预措施: TTP273 (Drug)
TTP273 150 mg daily
Experimental
Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks
干预措施: TTP273 (Drug)
TTP273 150 mg daily
Experimental
Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Two matching placebo tablets administered orally twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c from baseline at 12 weeks
时间窗: Day 1 to Week 12
次要结局
- Blood Pressure(Day 1 to Week 14)
- Hematology(Day 1 to Week 14)
- Percentage of subjects who achieve HbA1c <7% at 12 weeks(Day 1 to Week 12)
- Adverse Events(Day 1 to Week 14)
- Pulse(Day 1 to Week 14)
- Change in insulin levels from baseline at 12 weeks(Day 1 to Week 12)
- Electrocardiogram Parameters(Day 1 to Week 14)
- Urinalysis(Day 1 to Week 14)
- Change in body weight from baseline at 12 weeks(Day 1 to Week 12)
- Change in plasma glucose levels from baseline at 12 weeks(Day 1 to Week 12)
- Change in lipid Levels from baseline at 12 weeks(Day 1 to Week 12)
- Change in C-peptide levels from baseline at 12 weeks(Day 1 to Week 12)
- Blood Chemistry(Day 1 to Week 14)
研究者
相似试验
进行中（未招募）
2 期
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)NCT06643481Novartis Pharmaceuticals251
已完成
2 期
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back PainModerate to Severe Acute Lower Back PainNCT05096494Scilex Pharmaceuticals, Inc.76
撤回
2 期
A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's DiseaseTremorParkinson's DiseaseNCT03436953Jazz Pharmaceuticals
已完成
2 期
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber NeuropathySmall Fiber NeuropathyNCT03304522Vertex Pharmaceuticals Incorporated89
终止
2 期
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative ColitisColitis, UlcerativeNCT03893565GlaxoSmithKline104