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

NCT06952231 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-30

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Sitagliptin + Metformin

Self administration of Sitagliptin (as phosphate monohydrate) 50 mg twice daily plus metformin HCl 1000 mg twice daily

DRUG

Empagliflozin + Metformin

Self administration of Empagliflozin 12.5 mg twice daily plus metformin HCl 1000 mg twice daily.

Sponsors & Collaborators

  • University of Lahore Hospital (ULH)

    collaborator NETWORK

  • University of Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06952231 on ClinicalTrials.gov