drugset / Trial / NCT06952231

Effect of Sitagliptin and Empagliflozin in Combination With Metformin on Hs-CRP Levels in Patients With Type 2 Diabetes Mellitus

NCT06952231

RandomizedParallel-groupOpen-labelDiagnostic

Summary

The goal of this clinical trial is to compare the effects of Sitagliptin and Empagliflozin in combination with metformin on High sensitivity C reactive proteins (hs-CRP) levels and efficacy in T2DM patients. The main question aims to answer are the difference in effect of Sitagliptin with metformin and Empagliflozin with metformin on the levels of hs-CRP, HbA1C, Fasting blood glucose and BMI in patients with type 2 diabetes millitis. The sample size for the trial is 25 participants in each group based on 95% level of confidence and 80% power of the study. Fifty participants fulfilling the eligibility criteria will be randomly divided into two groups * Group A will be taking sitagliptin 50 mg along with metformin 1000mg BD for 12 weeks and group B will be taking Empagliflozin 12.5mg along with metformin 50mg for 12 weeks. * They will visit the hospital fortnightly for check up for 1st month and then monthly for tests * Participants will keep the record of their fasting blood glucose levels and any adverse effects during course of study. Primary outcomes measures: hs-CRP Secondary outcome measures: HbA1c, fasting blood glucose (FBG), body mass index (BMI).

Timeline

Start
2024-05-21
Primary completion
2024-12-10
Completion
2025-01-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 12.5 mg
Comparator Sitagliptin Small molecule 50 mg
Comparator Metformin Small molecule 1000 mg

Indications