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

Sponsor
Laboratorios Silanes S.A. de C.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT01429818
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
6
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glimepiride/metformin

Drug: Glimepiride/metformin
4/1000 mg tablets once a day foe eight weeks
Other Names:
  • GLIMETAL

    		•
    Active Comparator: Metformin

    Drug: Metformin
    1000 mg tablets once daily for eight weeks
    Other Names:
  • PREDIAL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. EDVI [8 weeks]

      endothelial-dependent vasodilation index

    2. MFR [8 weeks]

      myocardial flow reserve

    3. %ΔMBF [8 weeks]

      percentage of the change between rest and CPT

    Secondary Outcome Measures

    1. Fasting glucose [8 weeks]

    2. Glycated hemoglobin [8 weeks]

    3. Adverse effects [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México Mexico city Distrito Federal Mexico 04510

    Sponsors and Collaborators

    • Laboratorios Silanes S.A. de C.V.

    Investigators

    • Study Director: Jorge González, MD, Laboratorios Silanes S.A. de C.V.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laboratorios Silanes S.A. de C.V.
    ClinicalTrials.gov Identifier:
    NCT01429818
    Other Study ID Numbers:
    • PET-GLI01
    First Posted:
    Sep 7, 2011
    Last Update Posted:
    Sep 7, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Laboratorios Silanes S.A. de C.V.
    Endothelial dysfunction
    Diabetes mellitus
    glimepiride
    metformin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Metformin
    Glimepiride

    Study Results

    No Results Posted as of Sep 7, 2011