A Comparative study to evaluate the Efficacy and Safety of Teneligliptin versus Vildagliptin as an add-on to Metformin in the treatment of Type 2 Diabetes Mellitus at a tertiary care hospital

Praveen A0 个研究点目标入组 0 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.Patients willing to give written informed consent.(Annexure 1)
•2.Patients of either sex aged 18 -80 years
•3.Patients with Type 2 DM according to American Diabetes Association (ADA) criteria (FBS >126 mg/dl, PPBS >200 mg/dl.)
•4.Type 2 DM who do not achieve glycemic target with metformin alone (upto 2g/day) for 6 months.
•5.Patients with HbA1c levels between 7% and 9% on monotherapy with Metformin 1.5 -2g/day for 6 months prior to visit

•. Exclusion criteria :
•1.Patients who suffered an attack of acute coronary syndrome, transient ischemic attack or stroke in the past three months.
•2.Patients with hepatic disease (serum level of ALT, AST, Alkaline phosphatase >3times the upper limit of normal)
•3.Patients with severe ketosis, coma or reduced level of consciousness within the past 6 months due to diabetes.
•4.Severe infection, pre or post operative, severe trauma.
•5.History of a chronic intestinal disease associated with absorption and digestive problems.
•6.Moderate or severe renal dysfunction (creatinine clearance <50ml/min, serum creatine level >1.5mg/dl in men and 1.3mg/dl in females.
•7.Subjects with history of type 1 DM or secondary form of diabetes due to pancreatic diseases, pancreatic tumors pheochromocytoma, cushings syndrome, haemochromatosis drugs ,insulin receptors etc.
•8.Medical history of pancreatitis with history of alcohol and drug abuse.
•9.Pregnant and lactating mothers

发起方

Praveen A