Endothelial Disfunction Treatment With Glimepiride/Metfor... | NCT01429818

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

NCT01429818

Sponsor

Laboratorios Silanes S.A. de C.V.

Status

Completed

Last Update Posted

Sep 7, 2011Estimated

Enrollment

16Actual

Phase

Phase 4

Conditions

Endothelial Dysfunction
Diabetes Mellitus

Interventions

Glimepiride/metformin
Metformin

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 5, 2011

First Submission Date that Met QC Criteria

Sep 6, 2011

First Posted Date

Sep 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2011

Last Update Posted Date

Sep 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glimepiride/metformin	Experimental		Drug: Glimepiride/metformin
Metformin	Active Comparator		Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glimepiride/metformin	Drug	4/1000 mg tablets once a day foe eight weeks	Glimepiride/metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Fasting glucose		8 weeks
Glycated hemoglobin		8 weeks
Adverse effects

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jorge González, MD	Laboratorios Silanes S.A. de C.V.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México		Mexico City	Mexico City	04510	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C057619	glimepiride
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided