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

September 6, 2011 updated by: Laboratorios Silanes S.A. de C.V.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico city, Distrito Federal, Mexico, 04510
        • Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin
Drug: Metformin
1000 mg tablets once daily for eight weeks
Other Names:
  • PREDIAL
Experimental: Glimepiride/metformin
Drug: Glimepiride/metformin
4/1000 mg tablets once a day foe eight weeks
Other Names:
  • GLIMETAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDVI
Time Frame: 8 weeks
endothelial-dependent vasodilation index
8 weeks
MFR
Time Frame: 8 weeks
myocardial flow reserve
8 weeks
%ΔMBF
Time Frame: 8 weeks
percentage of the change between rest and CPT
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting glucose
Time Frame: 8 weeks
8 weeks
Glycated hemoglobin
Time Frame: 8 weeks
8 weeks
Adverse effects
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 5, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET-GLI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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