NCT03925701

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
32mo left

Started Apr 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Apr 2019Dec 2028

Study Start

First participant enrolled

April 1, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

9.7 years

First QC Date

April 22, 2019

Last Update Submit

April 26, 2019

Conditions

dm

Outcome Measures

Primary Outcomes (1)

  • number of patients with improved nafld and insulin resistance

    number of patients showing improved nafld and insulin resistance

    6 months

Study Arms (2)

vildagliptin

EXPERIMENTAL

vildagliptin 50 mg twice daily

Drug: Vildagliptin

vildagliptin\metformin

ACTIVE COMPARATOR

vildagliptin\\metformin twice daily

Drug: vildagliptin\metformin

Interventions

VildagliptinDRUG

vildagliptin twice daily

Also known as: dibavally
vildagliptin
vildagliptin\metforminDRUG

vildagliptin\\metformin twice daily

Also known as: dibavally plus
vildagliptin\metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NAFLD and type 2 DM

You may not qualify if:

  • Viral hepatitis.
  • Child score more than 6.
  • renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, 35111, Egypt

RECRUITING

MeSH Terms

Interventions

Vildagliptin

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Aya G Moussa, Msc

    Tanta University - Faculty of Pharmacy

    PRINCIPAL INVESTIGATOR

  • Osama M Ibrahim, Prof

    Prof of Clinical Pharmacy

    PRINCIPAL INVESTIGATOR

  • Gamal Alazab, ass. Prof.

    Prof of Clinical Pharmacy

    STUDY DIRECTOR

  • Yasser Abdel Raouf, Ass Prof

    Tanta University-Faculty of Medicine

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 24, 2019

Study Start

April 1, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 29, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)