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

Laboratorios Silanes

Status and phase: Completed; Phase 4

Conditions: Endothelial Dysfunction; Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Glimepiride/metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01429818

PET-GLI01

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Glimepiride/metformin

Experimental group

Treatment:

Drug: Glimepiride/metformin

Metformin

Active Comparator group

Treatment:

Drug: Metformin