NCT05801627

SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin

A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase III Clinical Trial for the Efficacy and Safety of Fugliglitinate Benzoate Tablets in Patients With Type 2 Diabetes Who Cannot be Effectively Controlled by Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in T2DM patients uncontrolled by metformin, 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 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 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 Metformin ≥1500mg
DRUG	Placebo	Placebo (2 tablet) and Metformin ≥1500mg

Timeline

• Start date: 2020-05-06
• Primary completion: 2022-05-24
• Completion: 2022-05-24
• First posted: 2023-04-06
• Last updated: 2023-04-06

Locations

1 site across 1 country: China