Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 With Additional 28-week Open-label Treatment to Evaluate the Safety of HMS5552 Alone in T2DM Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03173391

Enrollment

463

Registered

2017-06-01

Start date

2017-07-18

Completion date

2020-11-30

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

GKA, T2DM, HMS5552, monotherapy

Brief summary

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.

Detailed 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.

Interventions

DRUGHMS5552

BID Oral administration

DRUGPlacebo

BID Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Male or female, aged 18\ 75 years old 2. naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 \< BMI \< 35.0 kg/m2 at screening;

Exclusion criteria

1. T1DM 2. Fasting C-peptide \<1.0 ng/ml (0.33 nmol/L) at screening 3. 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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in HbA1c	24 weeks	The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment

Secondary

Measure	Time frame	Description
The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline	24 weeks	The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline in T2DM subjects after 24-week double-blind treatment
The change of fasting plasma glucose (FPG) from baseline	24 weeks	The change of fasting plasma glucose (FPG) from baseline in T2DM subjects after 24-week double-blind treatment
The proportion of subjects with HbA1c < 7.0%	24 weeks	The HbA1c response rate in T2DM subjects after 24-week double-blind treatment
Incidence of Treatment-Emergent Adverse Events over time	52 weeks	including incidence of adverse events, incidence of hypoglycemic events, physical examination, vital signs, 12-lead ECG, clinical laboratory examinations (routine blood test, blood biochemistry and routine urine test).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026