Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336310
Status:
UNKNOWN
Last Update Posted:
2006-06-13
First Post:
2006-06-12
Brief Title:
A Double-Blind Randomized Parallel Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
A Double-Blind Randomized Parallel Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
NOT_YET_RECRUITING
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 purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients
Detailed Description:
This study is designed to evaluate the efficacy and safety of a new-brand of repaglinide X in comparison to Novonorm for the treatment of type 2 diabetes mellitus patients Mentally competent patients with age of 30 to 75 years old in Taiwan of either sex with type 2 diabetes mellitus will be included All eligible subjects will be randomized into treatment groups in 11 ratio The treatment will consist of either X or Novonorm tid before meal for 12 weeks of treatment The primary endpoints include the net change of HbAc fasting plasma glucoseFPGand postprandial plasma glucosePPGat the end of 12th week evaluation compared to the baseline visit Also safety profiles including adverse event such as hypoglycemia incidences blood pressure liver kidney function test will be monitored
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