EVALUATION OF EFFICACY AND SAFETY OF FDC OF THREE ANTIDIABETIC DRUGS VERSUS FDC OF TWO ANTIDIABETIC DRUGS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES: AN OPEN LABEL, RANDOMIZED, COMPARATIVE, MULTICENTRIC STUDY

Sun Pharma Laboratories Limited0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

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•The following points were considered for inclusion criteria in this study:
•1.Male or female patients who were aged between 18 years to 65 years
•2.Patients who were diagnosed with type 2 diabetes
•3.Patients who had HbA1c ratio of>=7.5 and<=10
•4.Patients who had BMI of>=23 and<=30kg/m2
•5.Patients who had postprandial blood glucose (2 hours post meal) concentration more than 200 mg/dl
•6.Patients who were on treatment with stable dose of fixed dose combination of Glimepiride 1 mg + Metformin 500 mg twice daily OR fixed dose combination of Glimepiride 2 mg + Metformin 500 mg twice daily for at least 12 weeks before enrolment
•7.Patients who willingly gave their informed consent

•The following points were considered for exclusion criteria in this study:
•1.Pregnant, lactating women or women of childbearing age who were not willing to use an acceptable method of birth control during the study period
•2.Patients who had type 1 diabetes
•3.Patients who had fasting blood glucose concentration more than 270 mg/dl
•4.Patients who had hypersensitivity to any of the investigational products
•5.Patients who had significant renal or hepatic impairment
•6.Patients who received long term insulin therapy (<= 3 days of treatment was allowed)
•7.Patients who had history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis
•8.Patients who were in a state of diabetic coma or pre coma
•9.Patients who had severe infection or serious trauma
•10.Alcohol abused patients
•11.Patients who were in New York Heart Association (NYHA) class III or IV category
•12.Patients who had congestive heart failure to be treated
•13.Patients who had inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption
•14.Patients who were judged unfit for this study by investigator
•15.Patients who were receiving Miconazole

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