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

Sponsor
University of Lahore
Study ID
NCT06952231
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sitagliptin + Metformin — DRUG
    Self administration of Sitagliptin (as phosphate monohydrate) 50 mg twice daily plus metformin HCl 1000 mg twice daily
  • Empagliflozin + Metformin — DRUG
    Self administration of Empagliflozin 12.5 mg twice daily plus metformin HCl 1000 mg twice daily.

Study Details

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).

Key Dates

Start date
May 21, 2024
Status verified
Feb 2025
Primary completion
Dec 10, 2024
Completion
Jan 5, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Group A
    Sitagliptin (as phosphate monohydrate) 50 mg twice daily plus metformin HCl 1000 mg twice daily
  • Active Comparator: Group B
    Empagliflozin 12.5 mg twice daily plus metformin HCl 1000 mg twice daily

Primary Outcome Measure

hs-CRP [ Time Frame: 12 weeks ]

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