NCT04161430View on ClinicalTrials.gov

A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

766

Participants

Timeline

Start Date

January 2, 2020

Primary Completion Date

June 27, 2022

Study Completion Date

June 27, 2022

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

DBPR108; Placebo matching sitagliptin

"Phase A (Weeks 1-24): DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.~Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks."

DRUG

Placebo matching DBPR108; Sitagliptin; DBPR108

"Phase A (Weeks 1-24): Placebo matching DBPR108 100mg once daily under fasted conditions for 24 weeks; Sitagliptin 100 mg once daily under fasted conditions for 24 weeks.~Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks."

DRUG

Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108

"Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.~Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks."

Trial Locations (2)

100000

Peking University First Hospital, Beijing

410005

the No, 1 People's Hospital of Changsha, Changsha

All Listed Sponsors
lead

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

NCT04161430 - A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients | Biotech Hunter | Biotech Hunter