NCT01507038已完成2 期
Phase II Clinical Trial to Investigate the Efficacy, Safety and Pharmacokinetics of YH14617 After Once Weekly or Biweekly Administration in Patients With Type 2 Diabetes Mellitus
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c at week 12
研究概览
简要总结
The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed a written informed consent voluntary, prior to the any procedure
- •Volunteers of aged between 20 years to 75 years
- •Have been diagnosed with type 2 diabetes at least 3 months prior to study
- •Have a body mass index (BMI) of > 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by > 5% in weight)
- •Have been treated with stable dose regimen of Metformin > 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration
- •Have an HbA1c between 7% and 10% inclusive
排除标准
- •Have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other GLP-1 receptor agonist, DPP4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration
- •Have acute disease, other untreated disease or diabetic complications that needs additional treatment
- •Have severe renal disorder(serum creatinine concentration > 1.5 times of normal upper limit) or liver disorder(liver enzyme > 2 times of normal upper limit)
- •Have blood pressure > 160/100mmHg
- •Have been hospitalized due to cardiac disorder(angina, cardiac infarction, heart failure and etc.) within 1 year prior to the first administration
- •Have history of critical disease within 1 year prior to the first administration
- •Have untreated malignant tumor or have history of significant malignant tumor within 5 years prior to the first administration
- •Have fasting plasma glucose(FPG) > 250mg/dl or have random glucose level > 350mg/dl
- •Have more than 1 history of severe hypoglycemia that needed others help within 3 months prior to the first administration
- •Have a known allergy or hypersensitivity to drugs
- •Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- •Participated in any other clinical trials within 30 days prior to the first administration
- •Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons other than above
研究组 & 干预措施
Group A
Experimental
干预措施: YH14617 (Drug)
Group B
Experimental
干预措施: YH14617 (Drug)
Group C
Experimental
干预措施: YH14617 (Drug)
Group D
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c at week 12
时间窗: Baseline, Week 12
次要结局
- Change from baseline in fasting plasma glucose at week 12(Baseline, Week 12)
- Change from baseline in 1,5-anhydroglucitol at week 12(Baseline, Week 12)
- Change from baseline in body weight at week 12(Baseline, Week 12)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in ChildrenPainNCT02542098Purdue Pharma LP
终止
2 期
Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the LungNon Small Cell Lung CancerNCT02485652Hanmi Pharmaceutical Company Limited162
已完成
2 期
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungAdenocarcinomaNCT02875340ValiSeek Limited8
招募中
2 期
YN001-004 in Patients With Coronary Atherosclerosis in AustraliaCoronary Atherosclerotic DiseaseCoronary Artery DiseaseNCT06700720Beijing Inno Medicine Co., Ltd.24
尚未招募
2 期
A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic SyndromesMyelodysplastic SyndromesMDSBone Marrow DiseaseAnemiaNCT06594965Hansoh BioMedical R&D Company176