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

This study has been completed.
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
First received: September 5, 2011
Last updated: September 6, 2011
Last verified: September 2011

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 Intervention Phase
Endothelial Dysfunction
Diabetes Mellitus
Drug: Glimepiride/metformin
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)

Resource links provided by NLM:

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • EDVI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    endothelial-dependent vasodilation index

  • MFR [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    myocardial flow reserve

  • %ΔMBF [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    percentage of the change between rest and CPT

Secondary Outcome Measures:
  • Fasting glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Glycated hemoglobin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429818

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

No publications provided

Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01429818     History of Changes
Other Study ID Numbers: PET-GLI01
Study First Received: September 5, 2011
Last Updated: September 6, 2011
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014