A Multi-center, Double-blind, Randomized, Placebo-controlled Study of TT223 in Patients With Type 2 Diabetes Treated With Metformin and/or TZD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 主要终点
- To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg.
研究概览
简要总结
This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Type 2 Diabetes for at least 6 months
- •Treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
- •BMI of 21-45 kg/m2, inclusive
- •HbA1c level of 7.50 - 10.00%, inclusive
- •If a female of childbearing potential, willing to utilize contraception from Screening through 4 weeks after the last dose of study drug
排除标准
- •Treatment with insulin, sulfonylurea, DPP-4 inhibitors, Symlin® and/or GLP-1 analogues ≤ 3 months prior to the Screening
- •Severe hypoglycemia ≤ 60 days prior to the Screening visit or currently diagnosed with having hypoglycemia unawareness
- •History of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
- •Previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
- •Myocardial infarction within the last 2 years, current congestive heart failure with NYHA class 2 or greater, or chronic atrial fibrillation
- •Current clinically significant and/or chronic illness
- •Takes regular courses of non-steroidal anti-inflammatory drugs (NSAIDS). If these medications are discontinued upon starting Screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the Study
- •Use of systemic corticosteroids (oral, suppository, injected). Use of inhaled or topical corticosteroids is permitted
研究组 & 干预措施
TT223 with Metformin and/or TZD
TT223 as a treatment for Type 2 diabetes is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD).
干预措施: TT223 with Metformin and/or TZD (Drug)
Placebo with Metformin and/or TZD
Placebo as a comparator is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD).
干预措施: Placebo with Metformin and/or TZD (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg.
时间窗: For the duration of the trial.
次要结局
- To evaluate the efficacy of TT223 as a treatment for Type 2 diabetes by comparing the change in HbA1c value from baseline between the TT223 and placebo groups.(For the duration of the trial.)
- To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing.(For the duration of the trial.)
- To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients.(Day 1 and Week 12 of treatment.)