Comparative Evaluation of Efficacy and Safety of Metformin Glimepiride combination (s) and Sitagliptin Metformin Combination Treatment in Patients with Type 2 Diabetes: A open label, randomized, multicentre, Investigator Initiated Study in Indian Population

SV Limited0 个研究点目标入组 270 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects aged between 18 â?? 65 years of either sex.
•2.Subjects newly diagnosed with Type 2 Diabetes.
•3.Subjects with uncontrolled Type 2 Diabetes currently on metformin monotherapy. Uncontrolled diabetes as:
•FBS ( >= 126mg/dL and <= 200 mg/dL) and or 2 h post prandial (>= 200 mg/dL)
•HbA1c levels >= 7.5% and <= 10% at screening (Visit 1).
•4.Women of childbearing potential who agree to not to become pregnant and use an appropriate contraceptive method (hormonal, IUD, or diaphragm).
•5.Subjects willing to sign the Informed Consent Form and comply with the study visit as per protocol and perform 5-point home blood glucose monitoring as per protocol.
•6.Subjects willing to provide audiovisual recording of the consent process.
•7.Agree to follow recommended diet plan and physical activity instructions throughout the study.

•1.Subjects with type 1 diabetes or secondary forms of diabetes.
•2.Patients requiring insulin for glycemic control and or History of Insulin usage during 3 months preceding enrollment.
•3.A pregnant or lactating women.
•4.A female subject intends to become pregnant during the expected study duration.
•5.Fasting Blood Sugar ( < 126mg/dL) and or 2 h post prandial ( < 200 mg/dL).
•6.HbA1c levels <= 7.5% and >= 10% at screening.
•7.Subjects who are currently on a combination therapy with 2 or more oral anti-diabetic agents.
•8.Subjects with history of diabetic ketoacidosis and vascular complications.
•9.Clinically significant renal disease with serum creatinine > 1.5 ULN.
•10.Clinically significant liver disease with ALT and AST values 2.5 times ULN.
•11.Congestive heart failure requiring pharmacological treatment.
•12.History of Unstable angina within the past six months.
•13.Acute metabolic diabetes complications during the 3 months prior to enrollment in this study.
•14.History of acute coronary syndrome within the past 6 months.
•15.Subjects on anti-tuberculosis treatment.
•16.Subjects on any other chronic ailment treatment such as HIV, hepatitis B, hepatitis C and chronic kidney failure.
•17.History of allergy to any of the drugs / investigational products.
•18.History of chronic alcoholism.
•19.Planned surgical intervention during the expected study duration.
•20.History of any surgical interventions during 3 months prior to enrollment.

发起方

SV Limited