To Compare the Efficacy of Vildagliptin-Metformin Versus Dapagliflozin-Metformin in Achieving Glycemic Control Among Patients with Type 2 Diabetes Mellitus

Department of Medicine1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2026年1月25日最近更新: 2026年1月7日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方: Department of Medicine
入组人数: 100
试验地点: 1

研究概览研究设计入排标准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 prospective randomized comparative study will evaluate the efficacy and safety of two antidiabetic drug combinations—vildagliptin-metformin versus dapagliflozin-metformin—in adult patients with Type 2 Diabetes Mellitus inadequately controlled on metformin monotherapy or treatment-naive. A total of 100 participants will be randomized into two equal groups. Glycemic parameters (FBS, PPBS, HbA1c), body weight, blood pressure, and adverse events will be assessed at baseline, 6 weeks, and 12 weeks. The study aims to generate comparative evidence to guide optimal combination therapy in Type 2 Diabetes Mellitus.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: None

入排标准

年龄范围: 30.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Adults above 30 years of age.
•Patients with HbA1c greater than 7%.
•Patients who are newly diagnosed (treatment-naive) OR inadequately controlled on Metformin monotherapy.
•Patients willing to participate and provide written informed consent.

排除标准

•Type 1 Diabetes Mellitus or Gestational Diabetes.
•Severe renal impairment (eGFR less than 45 mL/min/1.73 m²) or significant hepatic dysfunction.
•Patients currently on insulin or other OHAs (except prior Metformin).
•Known contraindication to Vildagliptin, Dapagliflozin, or Metformin.

研究者

发起方

Department of Medicine

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

Dr Shubhseerat Kaur

Sri Guru Ram Das Institute of Medical Sciences and Research vallah ,Amritsar ,Punjab ,India 143501

研究点 (1)

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