Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

NCT ID: NCT03819127

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Metformin

metformin 1 g twice a day for 24 weeks

Group Type ACTIVE_COMPARATOR

Metformin Pill

Intervention Type DRUG

Metformin plus vildagliptin

metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks

Group Type EXPERIMENTAL

Vildagliptin 50 MG Oral Tablet

Intervention Type DRUG

Metformin Pill

Intervention Type DRUG

Interventions

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Vildagliptin 50 MG Oral Tablet

Intervention Type DRUG

Metformin Pill

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Enzo Saretto Dante Vicari

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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01/2015

Identifier Type: -

Identifier Source: org_study_id

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