NCT04556851

HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	HSK7653 10 mg Q2W	HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
DRUG	HSK7653 25 mg Q2W	HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
DRUG	Placebo	Placebo 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.

Timeline

• Start date: 2020-09-29
• Primary completion: 2022-01-10
• Completion: 2022-08-08
• First posted: 2020-09-21
• Last updated: 2022-12-12

Locations

2 sites across 1 country: China