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

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ClinicalTrials.gov Identifier: NCT01429818
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Diabetes Mellitus Drug: Glimepiride/metformin Drug: Metformin Phase 4

Study Type : Interventional  (Clinical Trial)
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 : July 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Glimepiride/metformin Drug: Glimepiride/metformin
4/1000 mg tablets once a day foe eight weeks
Other Name: GLIMETAL
Active Comparator: Metformin Drug: Metformin
1000 mg tablets once daily for eight weeks
Other Name: PREDIAL



Primary Outcome Measures :
  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 Outcome Measures :
  1. Fasting glucose [ Time Frame: 8 weeks ]
  2. Glycated hemoglobin [ Time Frame: 8 weeks ]
  3. Adverse effects [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429818


Locations
Mexico
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.

Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01429818     History of Changes
Other Study ID Numbers: PET-GLI01
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Laboratorios Silanes S.A. de C.V.:
Endothelial dysfunction
Diabetes mellitus
glimepiride
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors