Skip to main content
OpenTrials
Completed

NCT Number: NCT03173391

Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hua Medicine Limited

Shanghai, Shanghai Municipality, 201203, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HMS5552

Drug

BID Oral administration

Other names: Glucokinase Activator (GKA)

Placebo

Drug

BID Oral administration

Primary outcomes

  1. Change from baseline in HbA1c

    Time frame: 24 weeks

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

Secondary outcomes

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

    Time frame: 24 weeks

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

  2. The change of fasting plasma glucose (FPG) from baseline

    Time frame: 24 weeks

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

  3. The proportion of subjects with HbA1c < 7.0%

    Time frame: 24 weeks

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

  4. Incidence of Treatment-Emergent Adverse Events over time

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hua Medicine Limited

Industry

Collaborators

  • Tigermed Consulting Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2017
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.