Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

University of Catania

Status and phase: Completed; Phase 4

Conditions: Mild Cognitive Impairment

Treatments: Drug: Vildagliptin 50 MG Oral Tablet; Drug: Metformin Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT03819127

01/2015

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Metformin

Active Comparator group

Description:

metformin 1 g twice a day for 24 weeks

Treatment:

Drug: Metformin Pill

Metformin plus vildagliptin

Experimental group

Description:

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

Treatment:

Drug: Metformin Pill

Drug: Vildagliptin 50 MG Oral Tablet