Prospective Cohort Study on Imeglimin: Safety, Efficacy, and Acceptability in Type 2 Diabetes Management

This study plans to conduct a cohort monitoring study on the use of Imeglimin in type 2 diabetic patients , incorporating both retrospective and prospective approaches. The research studies on the safety and efficacy of Imeglimin have already been conducted in various countries including japan . This study on Imeglimin aims to address several gaps in the current understanding of type 2 diabetes management.

        AIM: The study aims to determine the Safety, Efficacy, and Patient Acceptability of Imeglimin in the  management of Type 2 Diabetes Mellitus.       OBJECTIVE: To assess the Safety, Efficacy, and Patient Acceptability of Imeglimin in the management of  Type 2 Diabetes Mellitus.**STUDY DESIGN:**Observational Prospective Cohort Study.

**SAMPLE SIZE:**70.

Inclusion criteria:

1. The study population includes patients who are 18 years of age and older .
2. Patients only with type 2 diabetes mellitus .
3. Patients who are receiving Imeglimin.
4. Patients receiving Imeglimin for atleast 3 months.

Exclusion criteria:

1. Patient who are intolerant to imeglimin.
2. Patient who have stopped taking imeglimin .
3. Patient unwilling to give written informed consent.

Clinical Outcomes:**Primary Clinical Outcomes :****Change in HbA1c Levels:**Measure the reduction in HbA1c from baseline to the end of the study. A significant decrease indicates improved glycemic control.**Fasting Blood Glucose :**Monitor changes in fasting blood glucose levels.**Change in Body Weight:**Measure the reduction in body weight in kg from baseline to follow-up.**Change in Body Mass Index :**Assess changes in BMI, which provides insight into overall weight status       

Secondary Clinical Outcomes:

         

Weight Loss: Assess weight reduction and changes in BMI over time. Document waist circumference to track central obesity.

Fasting and Postprandial Glucose: Monitor reductions in fasting plasma glucose and postprandial glucose levels.

**Lipid Profile:**Track improvements in lipid levels like total cholesterol, LDL, HDL, and triglycerides to evaluate cardiovascular health.

Blood Pressure: Observe changes in both systolic and diastolic blood pressure to assess any cardiovascular benefits.

EXPECTED OUTCOME:

1. The study’s safety outcomes will focus on identifying adverse drug reactions associated with imeglimin, including their frequency and severity.
2. The efficacy outcomes of the study will focus on the improvement in glycemic control among patients with Type 2 Diabetes Mellitus. This will be assessed by observing reductions in HbA1c levels over the study period, along with decreases in both fasting and postprandial blood glucose levels.
3. The study will likely support oral Imeglimin as an effective and safe treatment option, contributing to better management of diabetes for the population. These findings could guide clinical protocols in tertiary care hospitals.