- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925701
Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
April 26, 2019 updated by: Sherief Abd-Elsalam
Clinical Study Evaluating the Effectiveness of Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Clinical study evaluating vildagliptin versus vildagliptin/metformin on nonalcoholic fatty liver disease with DM.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt, 35111
- Recruiting
- Tanta University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- NAFLD and type 2 DM
Exclusion Criteria:
- Viral hepatitis.
- Child score more than 6.
- renal impairment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: vildagliptin
vildagliptin 50 mg twice daily
|
vildagliptin twice daily
Other Names:
|
ACTIVE_COMPARATOR: vildagliptin\metformin
vildagliptin\metformin twice daily
|
vildagliptin\metformin twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients with improved nafld and insulin resistance
Time Frame: 6 months
|
number of patients showing improved nafld and insulin resistance
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Osama M Ibrahim, Prof, Prof of Clinical Pharmacy
- Principal Investigator: Aya G Moussa, Msc, Tanta University - Faculty of Pharmacy
- Study Director: Gamal Alazab, ass. Prof., Prof of Clinical Pharmacy
- Study Chair: Yasser Abdel Raouf, Ass Prof, Tanta University-Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2019
Primary Completion (ANTICIPATED)
December 1, 2028
Study Completion (ANTICIPATED)
December 1, 2028
Study Registration Dates
First Submitted
April 22, 2019
First Submitted That Met QC Criteria
April 23, 2019
First Posted (ACTUAL)
April 24, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 29, 2019
Last Update Submitted That Met QC Criteria
April 26, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- diabetes mellitus tanta
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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