Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437554
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2007-02-20
Brief Title:
Phase III Study for Glimepiride Metformin Hydrochloride Amaryl M Slow Release SR
Sponsor:
Handok Inc
Organization:
Handok Inc
Study Overview
Official Title:
A 16-Week Controlled Double Blind Double Dummy Randomized Two Arm Parallel-Group Study to Compare the Efficacy and Safety of Amaryl M 1250 mg bid vs Amaryl M SR 2500 mg od in Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2007-11
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:
Primary
To show the equivalence in terms of efficacy glycated hemoglobin HbA1c of glimepiridemetformin slow-release combination tablet Amaryl M SR 2500 once daily compared with fixed-dose glimepiridemetformin combination tablet Amaryl M 1250 twice a day on HbA1c in patients with type 2 Diabetes Mellitus DM
Secondary To compare the following parameters in two treatment arm
Efficacy Fasting Plasma Glucose FPG and Post-prandial two hours plasma glucose PP2h
Response rates in terms of HbA1c FPG
Patient compliance
Safety
episodes of hypoglycemia
adverse events
laboratory values including hematology blood chemistry and urinalysis
vital sign and physical examination
To show the equivalence in terms of efficacy glycated hemoglobin HbA1c of glimepiridemetformin slow-release combination tablet Amaryl M SR 2500 once daily compared with fixed-dose glimepiridemetformin combination tablet Amaryl M 1250 twice a day on HbA1c in patients with type 2 Diabetes Mellitus DM
Secondary To compare the following parameters in two treatment arm
Efficacy Fasting Plasma Glucose FPG and Post-prandial two hours plasma glucose PP2h
Response rates in terms of HbA1c FPG
Patient compliance
Safety
episodes of hypoglycemia
adverse events
laboratory values including hematology blood chemistry and urinalysis
vital sign and physical examination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None