NCT03819127

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

January 22, 2019

Last Update Submit

January 25, 2019

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Rate of Glycated hemoglobin (%)

    24 weeks

Study Arms (2)

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 TabletDrug: Metformin Pill

Interventions

Vildagliptin 50 MG Oral TabletDRUG
Metformin plus vildagliptin
Metformin PillDRUG
MetforminMetformin plus vildagliptin

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

VildagliptinTabletsMetformin

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical PreparationsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 28, 2019

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 28, 2019

Record last verified: 2019-01