NCT04390295

Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes

Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 Combined With Metformin in Metformin Monotherapy Poorly Glycemic Controlled Chinese Type 2 Diabetic Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to obtain information on efficacy and safety of SHR3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.

Detailed description

A phase III clinical study on efficacy and safety of SHR3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening. Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Placebo	Once daily, 24 weeks
DRUG	SHR3824	Once daily, 52 weeks
DRUG	metformin	Three times daily, 52 weeks

Timeline

• Start date: 2017-11-02
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2020-05-15
• Last updated: 2020-05-15

Locations

1 site across 1 country: China