CTRI/2025/12/099000尚未招募不适用
Comparative Effectiveness of Combination of Second-line oral anti-diabetic treatment among the patients of Type-2 DM: A Prospective, Observational, Hospital-based Study in JA group of Hospital of Gajra raja medical college, Gwalior.
Dr Tribeni Debbarma1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年12月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- To evaluate the changes in Glycated Hemoglobin and body mass index from baseline, 3 months, 6 months and 9 months among sulfonyluraes, DPP 4 inhibitors and sglt 2c groups
研究概览
简要总结
This study aims to compare 3 groups of second line oral hypoglycaemic drugs which are dpp 4 inhibitors, sulfonylureas and sodium glucose cotransporter 2 inhibitors which among these drugs provide the best glycaemic control among the diabetic patients with a hbaic values between seven to 10 percentage.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •• Diabetic patients with age group:18-65yrs • On Metformin Monotherapy for 3 months with inadequate glycemic control (HbA1c: 7-10% at baseline) will be given as an add-on therapy to Second-line drugs such as SUs (e.g.: glimepiride), DPP-4i (e.g.: Sitagliptin), SGLT-2i (e.g.: Dapagliflozin) as prescribed by treating physician.
- •• Patient willing to sign Informed and written consent.
排除标准
- •TYPE 1 DIABETES OR GESTATIONAL DIABETES, HISTORY OF INSULIN USE OR HISTORY OF OTHER INJECTABLE ANTI DIABETIC DRUG USE, SEVERE RENAL IMPAIREMENT WHICH IS EGFR LESS THAN 30ML PER MINUTE, SEVERE HEPATIC IMPAIREMENT, SEVERE CARDIOVASCULAR EVENTS, HISTORY OF DIABETIC KETOACIDOSIS, PREGNANCY OR LACTATION.
结局指标
主要结局
To evaluate the changes in Glycated Hemoglobin and body mass index from baseline, 3 months, 6 months and 9 months among sulfonyluraes, DPP 4 inhibitors and sglt 2c groups
时间窗: BASELINE, 3 MONTHS, 6 MONTHS AND 9 MONTHS
次要结局
- To Assess changes in Systolic BP & eGFR at Baseline, 3 months, 6 months & 9 months.(To Compare Adverse Events (e.g. Hypoglycemia, weight gain) caused among different treatment groups.)
研究者
Dr Tribeni Debbarma
Gajra Raja Medical College, Gwalior, M.P.
研究点 (1)
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