A comparative evaluation of Imeglimin versus Glimepiride in patients with type 2 Diabetes Mellitus in a tribal population of Gujarat
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving HbA1c less than 7%
研究概览
简要总结
This is an academic, hospital-based, interventional, prospective cohort study designed to compare the efficacy and safety of Imeglimin versus Glimepiride as add-on therapy to Metformin in patients with Type 2 Diabetes Mellitus (T2DM) belonging to a tribal population of Gujarat. The trial is being conducted at Zydus Medical College and Hospital, Dahod, as part of a postgraduate academic research project.
A total of 170 participants with uncontrolled T2DM on Metformin (HbA1c 7–10%) will be enrolled and randomized into two groups:
- Group A: Metformin + Glimepiride
- Group B: Metformin + Imeglimin
Participants will be followed for 3 months with monthly assessments of glycemic parameters (HbA1c, FBS, PPBS) along with body weight, blood pressure, and safety outcomes (including adverse events). Ophthalmic evaluation and relevant laboratory investigations (lipid profile, RFT, LFT, electrolytes, CBC) will also be performed.
The primary objective is to compare glycemic efficacy (HbA1c, FBS, PPBS). The secondary objectives include evaluating safety, changes in body weight, and blood pressure.
The study adheres to ethical standards, with Institutional Ethics Committee approval and written informed consent from all participants. Data will be analyzed using appropriate statistical tests (independent t-test). Being a single-center, self-funded academic trial, the results aim to provide evidence on whether Imeglimin offers superior efficacy and safety compared to Glimepiride in this specific population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent from participants as documented by signature
- •Type 2 Diabetes Mellitus
- •HbA1c 7 to 10%
- •Patient already on metformin with uncontrolled Type 2 diabetes.
排除标准
- •Type 1 Diabetes Patients
- •Hypersensitivity to Imeglimin, Sulfonylureas & Metformin
- •Chronic Kidney Diseases (eGFR less than 45ml/min)
- •Pregnant and lactating women
- •Corticosteroids within 3 months before enrollment or during period of study.
结局指标
主要结局
Proportion of patients achieving HbA1c less than 7%
时间窗: 3 months
次要结局
- possible secondary outcome - Reduced Incidence of hypoglycemic episodes.
研究者
Dr Yash Rajubhai Pathak
Zydus Medical College and Hospital