NCT05782192

SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Multi-center, Randomized, Double-blind, Placebo/Positive Parallel Phase III Clinical Trial to Evaluate the Efficacy and Safety of SAL067 in Type 2 Diabetes Patients Who Cannot Effectively Control Blood Glucose Through Diet and Exercise

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

Detailed description

All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or alogliptin group (25 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 and alogliptin groups continued the same treatment until the end of the whole 52 weeks.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	SAL067	SAL067 6mg(2 tablet) and placebo 25mg (1 tablet)
DRUG	Alogliptin	Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet)
DRUG	Placebo	placebo 6mg (2 tablet) and placebo 25mg (1 tablet)

Timeline

• Start date: 2019-06-13
• Primary completion: 2022-03-25
• Completion: 2022-03-25
• First posted: 2023-03-23
• Last updated: 2023-03-23

Locations

1 site across 1 country: China