JPRN-jRCT2080223726已完成3 期
A phase III, open-label, monotherapy and combination therapy long-term study of imeglimin (TIMES 2)
POXEL S.A./ CMIC Co., Ltd.0 个研究点目标入组 714 人开始时间: 2017年11月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 714
研究概览
简要总结
Imeglimin provides well-tolerated long-term safety and efficacy in both mono- and oral combination therapy in Japanese patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Main inclusion criteria:
- •1) Patients with type 2 diabetes mellitus, diagnosed for at least 12 weeks
- •2) HbA1c >=7.0% and < 10.0%
- •3) Patients with type 2 diabetes mellitus, diagnosed for at least 24 weeks
- •4) HbA1c >=7.5% and < 10.5%
- •5) Body Mass Index (BMI) >= 18.5
排除标准
- •Main exclusion criteria:
- •1) Patients with type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- •2) History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- •3) Cardiovascular or cerebrovascular disease within 24 weeks (myocardial infarction, stroke, unstable angina etc.)
- •4) Uncontrolled high blood pressure
- •5) Severe impairment of hepatic function
研究者
相似试验
已完成
3 期
Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)Cervical DystoniaNCT03617367Revance Therapeutics, Inc.357
已完成
3 期
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement TherapyPrimary Immune DeficiencyNCT00419341CSL Behring49
进行中（未招募）
3 期
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency DiseasesPrimary Immune DeficiencyNCT04640142Octapharma50
Unknown
1 期
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity PEK Fusion Protein VaccineCervical Intraepithelial NeoplasiaNCT01880411HealthBanks Biotech Co., Ltd.15
已完成
1 期
A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple MyelomaMultiple Myeloma in RelapseNCT03136653Molecular Partners AG33