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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03925701

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted April 29, 2019

Study Description

Brief summary:

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

  • Condition or Disease:dm
  • Intervention/Treatment: Drug: Vildagliptin
    Drug: vildagliptin\metformin
  • Phase: Phase 3
Detailed Description

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

Study Design
  • Study Type: Interventional
  • Estimated 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: April 2019
  • Estimated Primary Completion Date: December 2028
  • Estimated Study Completion Date: December 2028
Arms and interventions
Arm Intervention/treatment
Experimental: vildagliptin
vildagliptin 50 mg twice daily
Drug: Vildagliptin
vildagliptin twice daily
Active Comparator: vildagliptin\metformin
vildagliptin\metformin twice daily
Drug: vildagliptin\metformin
vildagliptin\metformin twice daily
Outcome Measures
  • Primary Outcome Measures: 1. number of patients with improved nafld and insulin resistance [ Time Frame: 6 months ]
    number of patients showing improved nafld and insulin resistance
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- NAFLD and type 2 DM

Exclusion Criteria:

- Viral hepatitis.

- Child score more than 6.

- renal impairment.

Contacts and Locations
Contacts

Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com

Locations

Egypt
Tanta University
Tanta

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

More Information
  • Responsible Party: Sherief Abd-Elsalam
  • ClinicalTrials.gov Identifier: NCT03925701 History of Changes
  • Other Study ID Numbers: diabetes mellitus tanta
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 29, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No