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

PHASE3CompletedINTERVENTIONAL
Enrollment

465

Participants

Timeline

Start Date

November 13, 2020

Primary Completion Date

January 21, 2022

Study Completion Date

August 29, 2022

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

HSK7653 10 mg Q2W

HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.

DRUG

HSK7653 25 mg Q2W

HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg (1 tablet) Q2W, oral, week 25 to week 52.

DRUG

Linagliptin 5 mg QD

Linagliptin 5 mg QD, placebo of HSK7653 25 mg (1 tablet) and 5 mg (2 tablets) Q2W, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.

Trial Locations (2)

100044

Peking University People's Hospital, Beijing

Unknown

Inner Mongolia Baogang Hospital, Baotou

All Listed Sponsors
lead

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

NCT04564872 - HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter