CTRI/2017/01/007651已完成3 期
A Multicentric, Randomized, Open Label, Comparative, Parallel assignment Clinical Trial to Evaluate the Safety and Efficacy of Fixed Dose Combinations (FDC) of Repaglinide (0.5mg / 1mg) + Voglibose (0.2mg / 0.3mg) tablets Versus Repaglinide (0.5mg / 1mg) tablets in Patients with Type 2 Diabetes Mellitus
Torrent Pharamceutical Ltd0 个研究点目标入组 210 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
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.Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus.
- •2.Patients who are inadequately controlled (HbA1C >= 7.0%) with metformin monotherapy at maximum tolerable stable dose (not less than 1000mg/day) for at least 1 month prior to screening.
- •3.Patients who have 2hr Post Prandial Glucose >= 200mg/dl at screening visit.
- •4.Patients willing to give informed consent
排除标准
- •1.Patients with Insulin Dependent Diabetes Mellitus (IDDM).
- •2.Patients with Fasting Plasma Glucose (FPG) >= 200 mg/dl and/or Glycosylated Hemoglobin (HbA1C) >= 9%.
- •3.Patients requires frequent insulin for adequate glycemic control
- •4.Patients with history of treatment failure or intolerance or hypersensitivity with meglitinides and/or alpha-glucosidase inhibitors.
- •5.Patients with history of acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- •6.Patients with history of inflammatory bowel disease, colonic ulcerations or intestinal obstructions.
- •7.Patients who are known seropositive cases of HIV, Hepatatis B or Hepatitis C.
- •8.Patients with clinically significant impaired renal or hepatic function. [Aspartate aminotransferase (AST) & Alanine transaminase(ALT) more than 2.5X the UNL and/or bilirubin more than 1.5X the UNL and/or serum creatinine >1.5 mg/dl.]
- •9.Patients planning to undergo any surgical procedure during their participation in the study (except minor procedures not associated with restricted intake of food and fluids).
- •10.History of malignancy in last 5 years.
- •11.Patients with history of alcohol or drug abuse.
- •12.Clinically Significant abnormal physical, laboratory, ECG findings and/or any other clinical condition or history at the screening examination, which would interfere with the study objectives.
- •13.Patients on any medications (other than metformin) which may interfere with study outcome.
- •14.History of angina, Myocardial Infarction (MI) or stroke within last 6 months prior to screening.
- •15.Pregnant or lactating women.
- •16.Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device)
- •17.Intake of any investigational drug within 3 months prior to the first dose of study drug
- •18.In the opinion of the investigator, patient is unable to cooperate with any study procedures, unlikely to adhere to the study protocol, keep appointments, or is planning to relocate during the study.
研究者
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