Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173391
• Other study ID #: HMM0301
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2020
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• HMS5552
BID Oral administration
• Placebo
BID Oral administration

Locations

Country	Name	City	State
China	Hua Medicine Limited	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Hua Medicine Limited	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c	The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment	24 weeks
Secondary	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	24 weeks
Secondary	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	24 weeks
Secondary	The proportion of subjects with HbA1c < 7.0%	The HbA1c response rate in T2DM subjects after 24-week double-blind treatment	24 weeks
Secondary	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).	52 weeks