Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 2:38 PM
Study NCT ID:
NCT02053103
Status:
TERMINATED
Last Update Posted:
2016-05-02
First Post:
2014-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 In Adult Subjects With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.
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?: