CTRI/2019/04/018763已完成3 期
Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, Clinical study to compare efficacy and safety of oral CPL-2009-0031 140 mg of Cadila Pharmaceutical Limited, India against innovator Sitagliptin 100 mg in patients with Uncontrolled Type-2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 355
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.Male and female adult patient of 18-65 years with uncontrolled type 2 diabetes Mellitus (T2DM).
- •2.Patients with HbA1c >= 7 to 10 and those on oral hypoglycemic agents <= 2 other than Insulin and Gliptins.
- •3.BMI in the range of 18.5 â?? 35 kg/m2.
- •4.All patients must be willing to give informed consent and can understand & complying protocol requirement.
- •5.Patients who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator.
- •6.Documented negative test for human immuno virus (HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV).
排除标准
- •1.Those who are on insulin and not ready for wash out of 3 months.
- •2.Those who are on gliptin and not ready for wash out of 3 months.
- •3.Those with a history of severe ketosis, diabetic coma or pre-coma, or type 1 diabetes.
- •4.Those scheduled for or who had undergone surgery.
- •5.Those with a severe infection or serious injury
- •6.Pregnant and lactating women.
- •7.Hypersensitivity and contraindication to DPP-IV inhibitors or excipients of investigational drug formulation.
- •8.Hypertensive patients with blood pressure >=160/100 mm of Hg.
- •9.History of ischemic heart disease (as evident from ECG), stroke and/or transient ischemic attack.
- •10.Debilitating neurological or psychiatric disorders
- •11.History or currently consuming abusing drugs or alcohol.
- •12.Serious hepatic or renal impairment (liver dysfunction as evidenced by SGPT/SGOT level of 2.5 X ULN and renal dysfunction as evidenced by creatinine level 2.5 X ULN).
- •13.Patient with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor.
- •14.Patient has any concurrent illness which, in the opinion of the investigator or coinvestigator, may interfere with treatment or evaluation of safety or completion of this study.
- •15.In the investigatorâ??s judgment, the patient is unable to adhere to the treatment regimen, protocol procedures or study requirements.
- •16.Participation in another clinical trial in the past 3 months.
- •17.Patients with history of smoking or currently having smoking habit will not be included in the study.
研究者
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