dmPhase 3NCT03925701
Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
A Phase 3 study testing Vildagliptin and vildagliptin\metformin in people with dm, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- dm
- What is being tested?
- Vildagliptin and vildagliptin\metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NAFLD and type 2 DM
Who cannot join
- Viral hepatitis.
- Child score more than 6.
- renal impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, 35111
Sherief Abd-Elsalam
About this study
Official title: 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.
Read the detailed description
Clinical study evaluating vildagliptin versus vildagliptin/metformin on nonalcoholic fatty liver disease with DM.
- Conditions
- dm
- Being tested
- Vildagliptin, vildagliptin\metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Also called dibavally
vildagliptin twice daily
vildagliptin\metforminDrug
Also called dibavally plus
vildagliptin\metformin twice daily
| Study group | Role | What they receive |
|---|---|---|
| vildagliptin | Experimental | vildagliptin 50 mg twice daily Receives: Drug: Vildagliptin |
| vildagliptin\metformin | Active comparator | vildagliptin\metformin twice daily Receives: Drug: vildagliptin\metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with improved nafld and insulin resistance
number of patients showing improved nafld and insulin resistance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Apr 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for dmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Aya G Moussa, Msc, Principal investigator, Tanta University - Faculty of PharmacyOsama M Ibrahim, Prof, Principal investigator, Prof of Clinical PharmacyGamal Alazab, ass. Prof., Study director, Prof of Clinical PharmacyYasser Abdel Raouf, Ass Prof, Study chair, Tanta University-Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925701
- Sponsor's protocol ID
- diabetes mellitus tanta
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effectiveness of Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
- ClinicalTrials.gov ID
- NCT03925701
- Acronym / sponsor ID
- diabetes mellitus tanta
- Conditions
- dm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM.
Detailed description
Clinical study evaluating vildagliptin versus vildagliptin/metformin on nonalcoholic fatty liver disease with DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vildagliptin | Experimental | Drug: Vildagliptinvildagliptin 50 mg twice daily |
| vildagliptin\metformin | Active comparator | Drug: vildagliptin\metforminvildagliptin\metformin twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NAFLD and type 2 DM
Key exclusion criteria (3 listed)
- Viral hepatitis.
- Child score more than 6.
- renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VildagliptinAlso: dibavallyvildagliptin twice daily | Drug | vildagliptin |
| vildagliptin\metforminAlso: dibavally plusvildagliptin\metformin twice daily | Drug | vildagliptin\metformin |
Primary outcome
number of patients with improved nafld and insulin resistance
Time frame: 6 months
number of patients showing improved nafld and insulin resistance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aya G Moussa, Msc principal investigator
Tanta University - Faculty of Pharmacy
Osama M Ibrahim, Prof principal investigator
Prof of Clinical Pharmacy
Gamal Alazab, ass. Prof. study director
Prof of Clinical Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vildagliptin and vildagliptin\metformin in people with dm, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with improved nafld and insulin resistance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.