drugset / Trial / NCT02366377

The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

NCT02366377

Phase 1 Unknown 168 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Timeline

Start
2015-02
Primary completion
2016-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Henagliflozin Small molecule 5 mg
Subject Henagliflozin Small molecule 10 mg
Subject Henagliflozin Small molecule 20 mg
Background Metformin Small molecule 500 mg