drugset / Trial / NCT04564872

HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

NCT04564872

Phase 3 Completed 465 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy.

Timeline

Start
2020-11-13
Primary completion
2022-01-21
Completion
2022-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject HSK7653 Unknown 10 mg Oral
Subject HSK7653 Unknown 25 mg Oral
Comparator Linagliptin Small molecule 5 mg Oral