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

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

Overview[ - collapse ][ - ]

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	Endothelial Dysfunction Diabetes Mellitus
Intervention	Drug: Glimepiride/metformin Drug: Metformin
Phase	Phase 4
Sponsor	Laboratorios Silanes S.A. de C.V.
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

Tracking Information[ + expand ][ + ]

First Received Date	September 5, 2011
Last Updated Date	September 6, 2011
Start Date	July 2007
Estimated Primary Completion Date	January 2008
Current 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
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients
Official Title	Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)
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).
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Endothelial Dysfunction Diabetes Mellitus
Intervention	Drug: Glimepiride/metformin 4/1000 mg tablets once a day foe eight weeks Other Names: GLIMETALDrug: Metformin 1000 mg tablets once daily for eight weeks Other Names: PREDIAL
Study Arm (s)	Experimental: Glimepiride/metformin Active Comparator: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	16
Estimated Completion Date	January 2008
Estimated Primary Completion Date	January 2008
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Mexico

Administrative Information[ + expand ][ + ]

NCT Number	NCT01429818
Other Study ID Numbers	PET-GLI01
Has Data Monitoring Committee	No
Information Provided By	Laboratorios Silanes S.A. de C.V.
Study Sponsor	Laboratorios Silanes S.A. de C.V.
Collaborators	Not Provided
Investigators	Study Director: Jorge González, MD Laboratorios Silanes S.A. de C.V.
Verification Date	September 2011

Locations[ + expand ][ + ]