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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429818
• Other study ID #: PET-GLI01
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2011
• Last updated: September 6, 2011
• Start date: July 2007
• Est. completion date: January 2008

Study information

• Verified date: September 2011
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Endothelial Dysfunction

Intervention

Drug:
• Glimepiride/metformin
4/1000 mg tablets once a day foe eight weeks
• Metformin
1000 mg tablets once daily for eight weeks

Locations

Country	Name	City	State
Mexico	Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México	Mexico city	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EDVI	endothelial-dependent vasodilation index	8 weeks	No
Primary	MFR	myocardial flow reserve	8 weeks	No
Primary	%?MBF	percentage of the change between rest and CPT	8 weeks	No
Secondary	Fasting glucose		8 weeks	No
Secondary	Glycated hemoglobin		8 weeks	No
Secondary	Adverse effects		8 weeks	Yes