Evaluating vildagliptin and vildagliptin/metformin for liver disease in diabetes
Clinical Study Evaluating the Effectiveness of Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
This study is testing whether a diabetes medication called vildagliptin alone or with another drug, metformin, can help people with type 2 diabetes and liver disease feel better and improve their liver health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT03925701 on ClinicalTrials.gov |
What this trial studies
This clinical study compares the effects of vildagliptin alone versus a combination of vildagliptin and metformin on patients with nonalcoholic fatty liver disease (NAFLD) who also have type 2 diabetes mellitus (DM). The study aims to determine which treatment is more effective in managing liver health in this patient population. Participants will be monitored for changes in liver function and overall metabolic health throughout the trial. The study is designed as a Phase 3 interventional trial, indicating a focus on assessing the efficacy and safety of these treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with nonalcoholic fatty liver disease and type 2 diabetes mellitus.
Not a fit: Patients with viral hepatitis, significant liver impairment, or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with NAFLD and diabetes, potentially improving liver health and metabolic outcomes.
How similar studies have performed: While there have been studies on diabetes treatments affecting liver health, this specific comparison of vildagliptin and vildagliptin/metformin in NAFLD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * NAFLD and type 2 DM Exclusion Criteria: * Viral hepatitis. * Child score more than 6. * renal impairment.
Where this trial is running
Tanta
- Tanta University — Tanta, Egypt (Recruiting)
Study contacts
- Principal investigator: Aya G Moussa, Msc — Tanta University - Faculty of Pharmacy
- Study coordinator: Sherief Abd-Elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.