Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: Metformin Pill; Drug: Vildagliptin 50 MG Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin; metformin 1 g twice a day for 24 weeks	Drug: Metformin Pill
Experimental: Metformin plus vildagliptin; metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks	Drug: Metformin Pill; Drug: Vildagliptin 50 MG Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Vildagliptin
• Other Study ID Numbers: 01/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No