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Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT03925701
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
116
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Clinical study evaluating vildagliptin versus vildagliptin/metformin on nonalcoholic fatty liver disease with DM.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study Evaluating the Effectiveness of Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: vildagliptin

vildagliptin 50 mg twice daily

Drug: Vildagliptin
vildagliptin twice daily
Other Names:
  • dibavally

    		•
    Active Comparator: vildagliptin\metformin

    vildagliptin\metformin twice daily

    Drug: vildagliptin\metformin
    vildagliptin\metformin twice daily
    Other Names:
  • dibavally plus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of patients with improved nafld and insulin resistance [6 months]

      number of patients showing improved nafld and insulin resistance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • NAFLD and type 2 DM
    Exclusion Criteria:

    • Viral hepatitis.

    • Child score more than 6.

    • renal impairment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Tanta Egypt 35111

    Sponsors and Collaborators

    • Sherief Abd-Elsalam

    Investigators

    • Principal Investigator: Aya G Moussa, Msc, Tanta University - Faculty of Pharmacy
    • Principal Investigator: Osama M Ibrahim, Prof, Prof of Clinical Pharmacy
    • Study Director: Gamal Alazab, ass. Prof., Prof of Clinical Pharmacy
    • Study Chair: Yasser Abdel Raouf, Ass Prof, Tanta University-Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT03925701
    Other Study ID Numbers:
    • diabetes mellitus tanta
    First Posted:
    Apr 24, 2019
    Last Update Posted:
    Apr 29, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Metformin
    Vildagliptin

    Study Results

    No Results Posted as of Apr 29, 2019