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

NCT06952231 | Completed Phase 3

• 1 other identifier: ERC1212311
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• hs-CRP

  Difference in levels of hs-CRP before intervention and 4, 8 and 12 weeks of intervention

  12 weeks

Secondary Outcomes (3)

• HbA1C

  12 weeks

• Fasting Blood Glucose

  12 weeks

• Body mass index (BMI)

  12 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Sitagliptin + Metformin

Group B

ACTIVE COMPARATOR

Empagliflozin 12.5 mg twice daily plus metformin HCl 1000 mg twice daily

Drug: Empagliflozin + Metformin

Interventions

Sitagliptin + Metformin DRUG

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

Group A

Empagliflozin + Metformin DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients aged ≥18, both genders, who were taking Metformin ≥ 1000 mg daily since 1 year.

You may not qualify if:

• Patients with acute systemic infections (tonsillitis, chest infections, UTI, Gynecological infections) on the basis of history, examination and ancillary investigations when necessary. Patients with history of malignancy, angina and myocardial infarction, thyroid problems, Patients with liver disease/renal disease/ deranged liver function tests and renal function tests will be excluded from the study, Pregnancy, lactation.

Sponsors & Collaborators

• University of Lahore: lead
• University of Lahore Hospital (ULH): collaborator

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin Phosphate; Metformin; empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 30, 2025
• Study Start: May 21, 2024
• Primary Completion: December 10, 2024
• Study Completion: January 5, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)