Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519142
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2007-08-20
Brief Title:
Mitiglinide in Combination With Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus
Sponsor:
Elixir Pharmaceuticals
Organization:
Elixir Pharmaceuticals
Study Overview
Official Title:
A Rapid Onset and Short Duration Insulin Secretogogue Mitiglinide in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus A Randomized Double-blind Placebo-controlled Trial for 6 Months
Status:
COMPLETED
Status Verified Date:
2009-09
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 primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus T2DM whose blood sugar is not well controlled taking metformin alone This is a 24 week study which measures improvement in blood sugar after of treatment
Detailed Description:
This is a randomized double-blind placebo-controlled parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with T2DM who are less than adequately controlled on metformin alone Patients who are receiving metformin alone for T2DM will be randomized equally into one of three treatment groups
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