NCT06952231CompletedPhase 3
Effect of Sitagliptin and Empagliflozin in Combination With Metformin on Hs-CRP Levels in Patients With Type 2 Diabetes Mellitus
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
Source: ClinicalTrials.gov · Last updated 30 Apr 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 27 Mar 2025
- Start date
- 21 May 2024
- Primary completion date
- 10 Dec 2024
- Lead sponsor
- University of Lahore
- Diseases
- Type 2 diabetes
- NCT number
- NCT06952231
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 50
- From 21 May 2024 to the primary completion date, 10 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- Type 2 diabetes patients aged ≥18, both genders, who were taking Metformin ≥ 1000 mg daily since 1 year.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.