Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

Hua Medicine

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: HMS5552

Study type

Interventional

Funder types

Industry

Identifiers

NCT03173391

HMM0301

Details and patient eligibility

About

This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects will receive HMS5552 for 28 weeks.

Full description

This study is a phase III study in subjects with T2DM. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group with ratio 2:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week open-label treatment of HMS5552 75mg BID . After 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation.

Enrollment

463 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, aged 18~75 years old
naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 < BMI < 35.0 kg/m2 at screening;

Exclusion criteria

T1DM
Fasting C-peptide <1.0 ng/ml (0.33 nmol/L) at screening
Medical history of severe hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular,unstable or rapidly progressive kidney disease, active liver diseases,diagnosed mental disease,etc