NCT04124484

DBPR108 Tablets in Type 2 Diabetes Mellitus Patients

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluate DRBP108 in the treatment of type 2 diabetes mellitus. The patients were randomly allocated to four groups: 50 mg, 100 mg, 200 mg and placebo group.

Detailed description

This study was to evaluate DRBP108 in the treatment of type 2 diabetes mellitus. A total of 268 subjects were randomly allocated to four treatment arms: 50 mg, 100 mg, 200 mg or placebo group, in a 1:1:1:1 ratio.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)	One DBPR108 tablet(50mg) administered orally once a day + Two Placebos matching DBPR108 tablet(100mg) administered orally once a day for 12 weeks
DRUG	DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)	One DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
DRUG	DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)	Two DBPR108 tablets(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
DRUG	Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)	Two Placebos matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks

Timeline

• Start date: 2017-10-17
• Primary completion: 2019-02-27
• Completion: 2019-06-28
• First posted: 2019-10-11
• Last updated: 2019-10-15

Locations

1 site across 1 country: China