NCT07077525CompletedPhase 4
Effect of Vildagliptin Versus Dapagliflozin as Add on Therapy to Metformin on Cardiovascular Risk Factors
Effect of Vildagliptin Versus Dapagliflozin as Add on Therapy to Metformin on Cardiovascular Risk Factors in Egyptian Type II Diabetic Obese Patients: Potential Impact of Genetic Polymorphism
Source: ClinicalTrials.gov · Last updated 22 Jul 2025
Brief summary (registry, in English)
The overarching hypothesis of this study is that vildagliptin (vilda) as add on therapy to metformin (met) in Egyptian type 2 diabetic obese patient will produce an equal, if not better, glycemic control and will reduce cardiovascular risk factors compared to dapagliflozin (dapa). However, there are interindividual differences in response to vildagliptin among Egyptian population which might be due to gender difference and/ or mutation in one or more of the DDP-4 gene, GLP1 receptor gene and KATP channel gene. These potential differences could favor pharmacogenomic selection of candidate patient. Global aim of this study: To compare effects of the DPP-4 inhibitor (vildagliptin) versus SGLT4 inhibiter (dapagliflozin) as add on therapy to metformin to control cardiovascular risk factors in Egyptian obese patients with type 2 diabetes and furthermore to investigate the possible interindividual variation to vildagliptins response. Specific aims: Evaluation of efficacy and safety of vildagliptin plus metformin versus dapagliflozin plus metformin in Egyptian obese patients with type 2 diabetes mellitus (T2DM). Examining of interindividual difference in hypoglycemic response to the used treatment arms among participants of the study. Assessment of response in relation to sex difference in Egyptian population. Investigation of vasculoprotective effects of different treatment with special emphasis on atherogenesis. Investigating the efficacy of different treatment in controlling individual cardiovascular risk factors in preventing or slowing atherosclerotic cardiovascular diseases in people with diabetes Exploring of whether genetic variation in the DPP4 gene, GLP1 receptor and KATP channel affects incretin levels, insulin secretion, and glucose tolerance in participants of the study. Examining the associations between genetic variations of DPP-4 gene in men and women involved in this study
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 196 (actual)
- First submitted
- 24 Jun 2025
- Start date
- 1 Jun 2023
- Primary completion date
- 10 Aug 2024
- Lead sponsor
- Al-Azhar University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07077525
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 196
- From 1 Jun 2023 to the primary completion date, 10 Aug 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
- subjects with any serious medical condition requiring hospitalization
- subjects with unstable cardiac disorders such as heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe uncontrolled hypertension
- renal or liver failure
Lab values
- subjects using any drug that could interfere with the glucose level (e.g. systemic corticosteroids) and participation in any other clinical trial.
Other
- Diagnosis of T1DM
- females of childbearing potential or who are pregnant
- breast-feeding
Who the study is looking for
- The inclusion criteria involve Egyptian patients with newly documented T2DM diagnosis (naïve)
- 40-60 years old
- HbA1c level between 6.5% - 10.0% (47.5-107.7 mmol/mol) before study initiation
- obese (BMI ≥30 kg/m2)
- no history of established CV disease
- ability to understand and to sign a written informed consent document
- outpatients
- TSH and liver function within normal limit and no evidence of kidney diseases.
Age in the registry: 40 years to 60 years · 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 |
|---|---|---|---|
| Al-Azhar University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.