Vildagliptin in Older Adults With Diabetes and Mild Cogni... | NCT03819127

Studies
Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

NCT03819127

Sponsor

University of Catania

Status

Completed

Last Update Posted

Jan 28, 2019Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Mild Cognitive Impairment

Interventions

Vildagliptin 50 MG Oral Tablet
Metformin Pill

Countries

Not provided

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Jan 22, 2019

First Submission Date that Met QC Criteria

Jan 25, 2019

First Posted Date

Jan 28, 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

Jan 25, 2019

Last Update Posted Date

Jan 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study investigates the effect of vildagliptin, an inhibitor of the enzyme DPP-4, on the cognitive functioning of elderly diabetic patients with mild cognitive impairment (MCI) documented at mini mental state examination (MMSE).

In this prospective study, 60 diabetic elderly people were enrolled and divided according to their glycated hemoglobin (HbA1c) values in 2 groups: Group A, (HbA1c <7.5%, n=30) treated with metformin, and Group B (HbA1c >7.5%, n=30) treated with metformin plus vildagliptin. We evaluated MMSE, fasting plasma glucose (FPG) and HbA1c at baseline and after 24 weeks treatment.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin	Active Comparator	metformin 1 g twice a day for 24 weeks	Drug: Metformin Pill
Metformin plus vildagliptin	Experimental	metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks	Drug: Vildagliptin 50 MG Oral Tablet Drug: Metformin Pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin 50 MG Oral Tablet	Drug		Metformin plus vildagliptin
Metformin Pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of cognitive decline	Mini Mental State Examination (MMSE) score from 0 (worse) to 30 points (better). Score ≥18 and ≤23 indicates mild cognitive impairment (MCI).	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Rate of Glycated hemoglobin (%)	Laboratory assessment of Glycated hemoglobin	24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >65 years
MMSE score ≥18 and ≤23
diagnosis of diabetes mellitus

Exclusion Criteria:

heart failure
coronary heart disease
stroke
chronic kidney disease (G3 grade KDOQI)
liver cirrhosis
chronic respiratory failure
depression evaluated by Geriatric Depression (GDS, GDS >15)
diagnosis of dementia based on DSM 5 criteria
anticholinesterase or memantine therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077597	Vildagliptin
D013607	Tablets
D008687	Metformin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided