Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-31 @ 6:20 AM
Study NCT ID:
NCT02669732
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp
Sponsor:
Daiichi Sankyo Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.
Status:
COMPLETED
Status Verified Date:
2016-12
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 the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.
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?: