Clinical Study Evaluating Vildagliptin Versus Vildaglipti... | NCT03925701

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

NCT03925701

Sponsor

Sherief Abd-Elsalam

Status

Recruiting

Last Update Posted

Apr 29, 2019Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

Interventions

Vildagliptin
vildagliptin\metformin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Apr 22, 2019

First Submission Date that Met QC Criteria

Apr 23, 2019

First Posted Date

Apr 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2019

Last Update Posted Date

Apr 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vildagliptin	Experimental	vildagliptin 50 mg twice daily	Drug: Vildagliptin
vildagliptin\metformin	Active Comparator	vildagliptin\metformin twice daily	Drug: vildagliptin\metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin	Drug	vildagliptin twice daily	vildagliptin	dibavally

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with improved nafld and insulin resistance	number of patients showing improved nafld and insulin resistance	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NAFLD and type 2 DM

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, ass. prof.	Contact	00201147773440		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Aya G Moussa, Msc	Tanta University - Faculty of Pharmacy	Principal Investigator
Osama M Ibrahim, Prof	Prof of Clinical Pharmacy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University	Recruiting	Tanta		35111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077597	Vildagliptin

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided