NCT03940183

Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Trelagliptin Succinate Monotherapy for Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The trial used a randomized, double-blind, placebo-controlled, superior-effect design, multicenter clinical study. The trial was divided into a test group and a placebo group,the two groups were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of follow-up.

Detailed description

The trial was divided into a test group and a placebo group: the test group was given trelagliptin succinate tablets, and the placebo group was given placebo. The test group and the placebo group were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of follow-up. All subjects were asked to continue their current diabetes diet and physical activity treatment plan throughout the study period.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Trelagliptin Succinate	the experimental group will use trelagliptin succinate 100 mg for 24weeks
DRUG	Placebo Oral Tablet	the placebo Comparator groups use placebo oral tablet for 24weeks

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-12-03
• Completion: 2020-12-28
• First posted: 2019-05-07
• Last updated: 2021-01-12

Locations

1 site across 1 country: China