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

Phase 4

Completed

• Conditions: Endothelial Dysfunction; Diabetes Mellitus
• Interventions: Drug: Glimepiride/metformin; Drug: Metformin

• Registration Number: NCT01429818
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2011-09
• Study First Submitted: 2011-09-05
• Study First Submitted QC: 2011-09-06
• Last Update Submitted: 2011-09-06
• Study First Posted: 2011-09-07
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Both genders
• At least 18 years old
• Type 2 diabetes mellitus diagnosis
• Signed Informed Consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glimepiride/metformin	Glimepiride/metformin	-
Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
EDVI	8 weeks	endothelial-dependent vasodilation index
MFR	8 weeks	myocardial flow reserve
%ΔMBF	8 weeks	percentage of the change between rest and CPT

Secondary Outcome Measures

Name	Time	Method
Fasting glucose	8 weeks
Glycated hemoglobin	8 weeks
Adverse effects	8 weeks

Trial Locations

Locations (1)

Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México; 🇲🇽 Mexico city, Distrito Federal, Mexico