EUCTR2004-000313-19-HU进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK-0431 Monotherapy in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - MK-0431 Monotherapy Study in Patients with Type 2 DM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a.Patient has type 2 diabetes mellitus (T2DM).
- •b.Patient is ?18 and ?75 years of age.
- •c.Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.
- •d.Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period.
- •e.Patient is a male, or a female who is highly unlikely to conceive
- •f.HbA1c ?7% and ?10% measured at, or within 2 weeks prior to, Visit 3.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a.Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- •b.Patient has an ALT or AST >2.0-fold the Upper Limit of Normal (ULN)
- •c.Patient’s renal function is reflected below as indicated by a yes” answer to one of the following:
- •1)Patient is a male = 65 years of age and serum creatinine >1.8 mg/dL (159.1 µmol/L).
- •2)Patient is a male > 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
- •3)Patient is a female = 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
- •4)Patient is a female > 65 years of age and serum creatinine >1.3 mg/dL (114.9 µmol/L).
- •5)Creatinine clearance is <50 mL/min.
- •d.Patient has any of the following disorders within the past 6 months:
- •Acute coronary syndrome (e.g., MI or unstable angina)
- •Coronary artery intervention (e.g., CABG or PTCA)
- •Stroke or transient ischemic neurological disorder
- •Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
- •e.Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
- •f.Patient has a BMI <20 kg/m2 or >43 kg/m2
- •g.Patient has a positive urine pregnancy test
- •h.Patient has any other condition or therapy which, in the opinion of the investigator or Merck medical monitor, might pose a risk to the patient or make participation not in the patient’s best interest.
- •i.Patient has poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study.
- •a.Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- •b.Patient has an ALT or AST >2.0-fold the Upper Limit of Normal (ULN)
- •c.Patient’s renal function is reflected below as indicated by a yes” answer to one of the following:
- •1)Patient is a male = 65 years of age and serum creatinine >1.8 mg/dL (159.1 µmol/L).
- •2)Patient is a male > 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
- •3)Patient is a female = 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
- •4)Patient is a female > 65 years of age and serum creatinine >1.3 mg/dL (114.9 µmol/L).
- •5)Creatinine clearance is <50 mL/min.
- •d.Patient has any of the following disorders within the past 6 months:
- •Acute coronary syndrome (e.g., MI or unstable angina)
- •Coronary artery intervention (e.g., CABG or PTCA)
- •Stroke or transient ischemic neurological disorder
- •Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
- •e.Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
- •f.Patient has a BMI <20 kg/m2 or >43 kg/m2
- •g.Patient has a positive urine pregnancy test
- •h.Patient has any other condition or therapy which, in the opinion of the investigator or Merck medical monitor, might pose a risk to the patient or make participation not in the patient’s best interest.
- •i.Patient has poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study.
研究者
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