CTRI/2011/06/001846已完成4 期
An Prospective, Open label, Multicentric, Non-Comparative, study to evaluate the efficacy, safety and tolerability of fixed dose combination [FDC] Voglibose 0.3mg + Metformin (SR ) 500mg in treatment of patients with Type II diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.18 years of age, upper limit at the discretion of Investigator.
- •2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix B) at least 6 months prior to screening
- •3.Newly diagnosed Type 2 diabetes mellitus patients
- •4.Patients with type 2 diabetes mellitus who had previously received at least 3 months of continuous treatment with oral therapy of Metformin 1000 mg alone and is inadequately controlled [HbA1c 8% and HbA1c 11 %] during screening visit
- •5.Patient with BMI between 20 ? 35 Kg/m2
- •6.Patients whose baseline fasting plasma venous glucose (FPG) concentration ranging from 126mg/dl but 200mg/dl
- •7.Patients whose venous plasma glucose concentration is 200 mg/dl at 2hr postprandial (after a meal) but 300mg/dl
- •8.Patients with stable dietary and exercise pattern since three month and willing to follow the same for entire trial duration.
- •9.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed.
排除标准
- •1.Type-1 diabetes mellitus
- •2.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
- •3.Cardiac status New York Heart Association (NYHA) III-IV
- •4.Uncontrolled Blood pressure [ 140 Systolic and 90 Diastolic]
- •5.Impaired renal function as shown by, but not limited to, serum creatinine ¡Ý 1.5 mg/dL for males, or ¡Ý 1.4 mg/dL for females
- •6.Clinically significant peripheral edema
- •7.Acute infection
- •8.Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
- •9.Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range
- •10.Patients on steroids
- •11.Patient with anticipated need of surgery within study period.
- •12.Patient known to be suffering from any bleeding disorder.
- •13.Pregnancy or lactating women
- •14.Known hypersensitivity to any of the study drugs.
- •15.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
- •16.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
- •17.Diagnosis of dementia
- •18.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •19.Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- •20.Any disease or condition that in the opinion of the investigator may interfere with the completion of the study
研究者
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