Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: HMS5552; Drug: Placebo

• Registration Number: NCT03173391
• Lead Sponsor: Hua Medicine Limited

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.

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-01
• Study Start: 2017-07-18
• Status Verified: 2020-11
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMS5552	HMS5552	75mg BID
Placebo	Placebo	BID

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	24 weeks	The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hua Medicine Limited; 🇨🇳 Shanghai, Shanghai, China