Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment
NCT ID: NCT03819127
Last Updated: 2019-01-28
Study Results
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2015-01-31
2016-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Metformin
metformin 1 g twice a day for 24 weeks
Metformin Pill
Metformin plus vildagliptin
metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks
Vildagliptin 50 MG Oral Tablet
Metformin Pill
Interventions
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Vildagliptin 50 MG Oral Tablet
Metformin Pill
Eligibility Criteria
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Inclusion Criteria
* MMSE score ≥18 and ≤23
* diagnosis of diabetes mellitus
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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University of Catania
OTHER
Responsible Party
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Enzo Saretto Dante Vicari
Associate Professor
Other Identifiers
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01/2015
Identifier Type: -
Identifier Source: org_study_id
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