NCT01429818

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

6 months

First QC Date

September 5, 2011

Last Update Submit

September 6, 2011

Conditions

Endothelial DysfunctionDiabetes Mellitus

Keywords

Endothelial dysfunctionDiabetes mellitusglimepiridemetformin

Outcome Measures

Primary Outcomes (3)

  • EDVI

    endothelial-dependent vasodilation index

    8 weeks

  • MFR

    myocardial flow reserve

    8 weeks

  • %ΔMBF

    percentage of the change between rest and CPT

    8 weeks

Secondary Outcomes (3)

  • Fasting glucose

    8 weeks

  • Glycated hemoglobin

    8 weeks

  • Adverse effects

    8 weeks

Study Arms (2)

Glimepiride/metformin

EXPERIMENTAL
Drug: Glimepiride/metformin

Metformin

ACTIVE COMPARATOR
Drug: Metformin

Interventions

Glimepiride/metforminDRUG

4/1000 mg tablets once a day foe eight weeks

Also known as: GLIMETAL
Glimepiride/metformin
MetforminDRUG

1000 mg tablets once daily for eight weeks

Also known as: PREDIAL
Metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders
  • At least 18 years old
  • Type 2 diabetes mellitus diagnosis
  • Signed Informed Consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México

Mexico City, Mexico City, 04510, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

glimepirideMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jorge González, MD

    Laboratorios Silanes S.A. de C.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2011

First Posted

September 7, 2011

Study Start

July 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

ME(1)