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NCT06952231

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

Completed Phase 3 Last updated 30 April 2025
What this trial tests

Phase 3 trial testing Sitagliptin + Metformin in Diabetes Mellitus in 50 participants. Completed in 5 January 2025.

Timeline
21 May 2024
Primary endpoint
10 December 2024
5 January 2025

Quick facts

Lead sponsorUniversity of Lahore
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment50
Start date21 May 2024
Primary completion10 December 2024
Estimated completion5 January 2025
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

University of Lahore

Who can join

18 and older, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Sitagliptin + Metformin

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

Other University of Lahore trials

Trials by the same sponsor.

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Data sources for this page

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