Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT00941161
Status:
COMPLETED
Last Update Posted:
2010-05-18
First Post:
2009-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
Sponsor:
Laboratorios Silanes S.A. de C.V.
Organization:
Study Overview
Official Title:
Effect of Oral Combination Therapy of Metformin Extended Release Over Glimepiride in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus With Failure of Monotherapy
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to determinate the effect of combined oral therapy of long acting metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and monotherapy failure.
Detailed Description:
A randomized double-blind clinical trial, to determine the effect of combined therapy of oral prolonged-release metformin/glimepiride in a single dosage form on fasting glucose and HbA1c. Patients will be included in this study are patients with diabetes mellitus and secondary failure to monotherapy. Will also assess the effect of combined therapy on the oral lipid profile (total cholesterol, LDL, HDL, VLDL, Triglycerides) and on the sensitivity and insulin secretion. We evaluate the clinical measurements, laboratory and safety during 3 months, through the allocation of subjects to three study groups (metformin, glimepiride and metformin extended release / glimepiride)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: