Comparison of Effect of Sitagliptin and Empagliflozin in Combination With Metformin on High-Sensitivity C-Reactive Protein Levels in Patients With Type 2 Diabetes Mellitus
Abstract
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).
Conditions: Diabetes Mellitus.
Primary outcome: hs-CRP.
Enrollment: 50 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 50 participants or records.
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