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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01429818
First received: September 5, 2011
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
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 May 23, 2013