Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

Hua Medicine Limited463 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

463

Conditions

Diabetes Mellitus, Type 2

Interventions

HMS5552DRUG

BID Oral administration

PlaceboDRUG

BID Oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hua Medicine Limited

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change from baseline in HbA1c

The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment

Time frame: 24 weeks

Secondary Outcomes

The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline

The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline in T2DM subjects after 24-week double-blind treatment

Time frame: 24 weeks

The change of fasting plasma glucose (FPG) from baseline

The change of fasting plasma glucose (FPG) from baseline in T2DM subjects after 24-week double-blind treatment

Time frame: 24 weeks

The proportion of subjects with HbA1c < 7.0%

The HbA1c response rate in T2DM subjects after 24-week double-blind treatment

Time frame: 24 weeks

Incidence of Treatment-Emergent Adverse Events over time

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).

Time frame: 52 weeks

Data from ClinicalTrials.gov

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