Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-02 @ 12:14 PM
Study NCT ID:
NCT04556851
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd
Organization:
Study Overview
Official Title:
A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of HSK7653 as Monotherapy in Chinese Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2022-12
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 purpose of this study is to assess the efficacy of HSK7653 (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise.
Detailed Description:
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653 and matching placebo, or placebo only. During the open-label period, all participants will receive 25 mg dose of HSK7653.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTR20201759 | OTHER | www.chinadrugtrials.org.cn | View |