A study of the safety and effectiveness of Vildagliptin and Remogliflozin when added to Metformin in Type 2 Diabetes patients in Kanpur
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Detailed medical history
研究概览
简要总结
Background and Rationale Type 2 Diabetes Mellitus is a progressive chronic disease requiring treatment intensification over time to maintain glycemic control
While Metformin is the established Firstline therapy its efficacy diminishes as insulin resistance and beta cell dysfunction worsen
This necessitates add on therapies
The American Diabetes Association recommends several classes of drugs, including Dipeptidyl Peptidase 4 inhibitors and Sodium-Glucose Cotransporter2 inhibitors, for second line treatment.
Vildagliptin a DPP4 inhibitor is a well established weight neutral agent with a good safety profile
Remogliflozin etabonate is a newer SGLT2 inhibitor that not only improves glycemic control but also offers the additional benefits of weight loss and blood pressure reduction
Its availability at a lower cost in India makes it a potentially attractive and cost-effective option for a large patient population
While both drug classes are effective there is a lack of direct head to head comparative data between the established DPP4 inhibitor Vildagliptin and the newer more affordable SGLT2 inhibitor Remogliflozin especially within the Indian population
This study aims to address this gap by directly comparing their efficacy and safety as add on therapy in patients with T2DM inadequately controlled with metformin
Objectives
Primary Objective To compare the efficacy of vildagliptin and remogliflozin as add on therapy to metformin in patients with type 2 diabetes mellitus in terms of their effect on HbA1c levels
Secondary Objectives To compare the safety of vildagliptin and remogliflozin as add on therapy to metformin
To compare the effect of vildagliptin and remogliflozin on lipid profile and body weight
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 35 and 70 years all sexes 2.Diagnosed with T2DM with HbA1c more than 6.5 percentage 3.Currently taking a stable dose of metformin (more than equal to 1500 mg per day or maximum tolerated dose) for more than equal to months.
排除标准
- •Use of other anti-diabetic medications besides metformin Hepatic dysfunction (ALT and AST more than equal to 2.5 UNL or Bilirubin more than 2x UNL) Renal dysfunction (eGFR less than 45 ml per min per 1.73 m²) Active genitourinary tract infections and lower limb cellulitis or ulcers Known case of osteoporosis Known allergy to study medications Pregnant or nursing patients.
结局指标
主要结局
Detailed medical history
时间窗: Baseline Visit (Day 0) and Follow-up Visit (Day 90):
Systemic examination
时间窗: Baseline Visit (Day 0) and Follow-up Visit (Day 90):
blood sugar profile
时间窗: Baseline Visit (Day 0) and Follow-up Visit (Day 90):
others biochemical examination
时间窗: Baseline Visit (Day 0) and Follow-up Visit (Day 90):
次要结局
未报告次要终点
研究者
Dr Nilam Nigam
Rama Medical College Hospital and Research Centre, Kanpur