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临床试验/CTRI/2020/12/030147
CTRI/2020/12/030147招募中Unknown

Comparative study of efficacy, safety and patient compliance of Dapagliflozin and Metformin Vs Vildagliptin and Metformin combination therapy in newly diagnosed Type 2 diabetes patients

Kumar Gautam1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
180
试验地点
1
主要终点
Change in HbA1C level after 24 weeks of treatment.

研究概览

简要总结

Diabetes is one of the most common chronic and non communicable disease with more than 350 million cases wordwide. The disease burden contributed by India is steadily increasing from 26 million in 1990 to 65 million in 2016. The age standardized disease prevalence has increased by 39.6% during the same period. The treatment of the disease is costly and type 2 diabetes (T2DM) constitutes for approximately 90% of the disease burdeManagement of the disease is multimodal and focuses on lifestyle management, diabetes self management education and specific medication. For newly diagnosed T2DM patients choosing the appropriate drug or drug combination is crucial in achieving the goal of preventing or delaying complications and maintaining as well as improving quality of life.The management strategy must be specific, measurable, achievable, realistic and time limited.4 Choice of drugs for the treatment should be individualized taking in to consideration of the factors like HbA1c, body weight, hypoglycaemia, side effects, cost and convenience.4

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
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed T2DM patients with or without metformin therapy 2)HbA1C ≥7.5 3)Age 18-75 yrs.

排除标准

  • Type 1DM, Patient taking metformin 1000mg/day with poor glycemic control 2)eGFR <45 ml/min/1.73m2 3)CHF 4)Pregnancy 5)Lactation 6)Patients with Child bearing potential 7)Active Malignancy 8)Chronic inflammatory disorders 9)Chronic alcoholism 10)History of pancreatitis.

结局指标

主要结局

Change in HbA1C level after 24 weeks of treatment.

时间窗: After 24 weeks of treatment.

次要结局

  • 1)Body weight(2)Anthropometric measurements (Hip circumference, Hip-Waist ratio))

研究者

发起方
Kumar Gautam
申办方类型
Private medical college

研究点 (1)

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