CTRI/2011/091/000266已完成4 期
A Randomized, Open label, Multicentric, Comparative, Efficacy and Safety study of Early initiation Triple Oral Therapy of Fixed dose combination [FDC] of Glimepiride + Metformin SR + Pioglitazone Vs Fixed dose combination [FDC] of Dual oral therapy of Glimepiride + Metformin SR in patients with type 2 diabetes inadequately controlled with monotherapy of either Glimepiride or Metformin Plain/SR formulation
Abbott Healthcare Private Limited, Mumbai0 个研究点目标入组 104 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
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.Patients with type 2 diabetes mellitus who had previously received at least 3 months of continuous treatment with oral therapy of Metformin or Glimepiride alone and is inadequately controlled [HbA1c>8% and HbA1c < 11 %] during screening visit.
- •4.Patient with BMI between 20 ? 35 Kg/m2.
- •5.Patients with stable dietary and exercise pattern since three months and willing to follow the same for the entire trial duration.
- •6.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.Patients already on insulin therapy in addition to Glimepiride or Metformin therapy.
- •2.H/O earlier use of dual or triple OAD?s therapy.
- •3.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months.
- •4.Cardiac status New York Heart Association (NYHA) III-IV.
- •5.Uncontrolled Blood pressure [> 140 Systolic and > 90 Diastolic].
- •6.Impaired renal function as shown by, but not limited to, serum creatinine ≥ 1.5 mg/dL for males, or ≥ 1.4 mg/dL for females.
- •7.Clinically significant peripheral edema.
- •8.Acute infection.
- •9.Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis.
- •10.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.
- •11.Diabetics on steroids.
- •12.History of hypoglycemia unawareness.
- •13.Pregnancy or lactating women.
- •14.Known hypersensitivity to any Oral hypoglycemic agent.
- •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 and/or sponsor may interfere with the completion of the study.
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