Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HMS5552

75mg BID

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

BID Oral administration

Placebo

BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

BID Oral administration

Interventions

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HMS5552

BID Oral administration

Intervention Type DRUG

Placebo

BID Oral administration

Intervention Type DRUG

Other Intervention Names

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Glucokinase Activator (GKA)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No