Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients

Laboratorios Silanes S.A. de C.V.16 enrolled

Overview

The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Endothelial Dysfunction Diabetes Mellitus

Interventions

Glimepiride/metforminDRUG

4/1000 mg tablets once a day foe eight weeks

MetforminDRUG

1000 mg tablets once daily for eight weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Both genders * At least 18 years old * Type 2 diabetes mellitus diagnosis * Signed Informed Consent Exclusion Criteria: * History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases * Pregnancy or lactation * History of abuse and/or substance dependence within 6 months preceding the survey. * History of glimepiride or metformin allergy

Locations (1)

Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

EDVI

endothelial-dependent vasodilation index

Time frame: 8 weeks

MFR

myocardial flow reserve

Time frame: 8 weeks

%ΔMBF

percentage of the change between rest and CPT

Time frame: 8 weeks

Secondary Outcomes

Fasting glucose

Time frame: 8 weeks

Glycated hemoglobin

Time frame: 8 weeks

Adverse effects

Time frame: 8 weeks

Data from ClinicalTrials.gov

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