Trial intelligence / Profile preview

Glimepiride/Metformin for Endothelial Dysfunction in Type 2 Diabetes

NCT01429818Phase 4

Key facts

Status: Completed
Start: Jul 2007
Primary completion: Jan 2008
Countries: 1
Sponsor: Laboratorios Silanes
Modality: Orthosteric Ligands

Drugs: glimepiride
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 4, randomised trial of glimepiride in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Laboratorios Silanes. Primary endpoints: Endothelial Dependent Vasodilation Index at 8 weeks, Myocardial Flow Reserve at 8 weeks and 1 more. Started Jul 2007; status: completed.

Design

2 arms

Study design: Randomized

Glimepiride/metformin
Glimepiride/metformin 4/1000 mg tablets once a day
Metformin
Metformin 1000 mg tablets once daily

Who it enrols

Adult patients with type 2 diabetes mellitus, excluding those with smoking history, hypertension, dyslipidemia, ischemic heart disease, or autoimmune rheumatic diseases.

Endpoints

Primary

Endothelial Dependent Vasodilation Index8 weeks
Myocardial Flow Reserve8 weeks
Percentage Change in Myocardial Blood Flow8 weeks

Secondary

Fasting glucose8 weeks
Glycated hemoglobin8 weeks
Adverse effects8 weeks

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