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Completed

NCT Number: NCT01429818

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

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).

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Key information

Conditions

Endothelial Dysfunction Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Mexico City, 04510, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glimepiride/metformin

Drug

4/1000 mg tablets once a day foe eight weeks

Other names: GLIMETAL

metformin

Drug

1000 mg tablets once daily for eight weeks

Other names: PREDIAL

Primary outcomes

  1. EDVI

    Time frame: 8 weeks

    endothelial-dependent vasodilation index

  2. MFR

    Time frame: 8 weeks

    myocardial flow reserve

  3. %ΔMBF

    Time frame: 8 weeks

    percentage of the change between rest and CPT

Secondary outcomes

  1. Fasting glucose

    Time frame: 8 weeks

  2. Glycated hemoglobin

    Time frame: 8 weeks

  3. Adverse effects

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study title

Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 7, 2011
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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