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

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•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

Not specified