Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 8:45 PM
Study NCT ID:
NCT02831361
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2016-06-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in Combination With Metformin in Type 2 DM (ZEUS II Study)
Sponsor:
LG Life Sciences
Organization:
Study Overview
Official Title:
A Multinational, Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Gemigliptin 50 mg q.d Compared With Placebo Added to Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin
Status:
COMPLETED
Status Verified Date:
2018-02
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 objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or on insulin in combination with metformin stably for 8 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: