A Randomised Open Label Study on the efficacy and safety of Metformin Monotherapy vs Metformin- Dapagliflozin combination therapy in the treatment of newly diagnosed type 2 diabetic patients in the urban population of chennai

Dr Sridevi S A (self)1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2023年5月30日最近更新: 2024年5月30日

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 200
试验地点: 1
主要终点: hbA1C

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study mainly aims at introducing metformin- dapagliflozin combination therapy as compared to conventional metformin monotherapy in newly diagnosed type 2 diabetes mellitus patients associated with hypertension, obesity and hyperlipidemia. The study aims at bringing holistic approach to bring euglycemic control , reduce the duration of drug therapy and follow the latest american Diabetes Association (ADA) 2023 guidelines which states to target the associated factors causing peripheral insulin resistance.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 35.00 Year(s) 至 55.00 Year(s)（—）
性别: All

入选标准

•newly diagnosed type 2 diabetes mellitus with HbA1C more than 6.5 % associated with hypertension, obesity, hyperlipidemia.

排除标准

•age less than 35 and more than 55 type 1 diabetes mellitus hypertensives, hyperlipidemics renal or hepatic disease pregnancy lactation.

结局指标

主要结局

hbA1C

时间窗: 3rd month, 6th month, 12th month

次要结局

fasting blood sugar, post prandial blood sugar, lipid profile, BP, waist circumference ratio , urine routine(QOL(quality of life) index)

研究者

发起方

Dr Sridevi S A (self)

申办方类型

Other [self]

研究点 (1)

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