Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

Type 2 Diabetes Clinical Trial

Official title:

A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386982
• Other study ID #: HMM0103
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2015
• Last updated: May 13, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female,age 18-65 years

• Has type 2 diabetes mellitus

• BMI 20 to 29kg/m2

• Willingness to adhere to the protocol requirement

Exclusion Criteria:

• Patients with type1 diabetes mellitus

• Received any antidiabetic drug within run-in or during screening

• Hepatic diseases

• Kidney diseases

• Clinical abnormal finding in EVG,labs and physical exams

• Women of child-bearing potential

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• HMS5552

Locations

Country	Name	City	State
China	The 1st Betuhune Hospital of Jilin University	Changchun

Sponsors (1)

Lead Sponsor	Collaborator
Hua Medicine Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	beta cell function	will be assessed by change of beta cell function index	4 weeks	No
Primary	HbA1		4 weeks	No
Primary	24-hour glucose change		4 weeks	No
Secondary	The study drug concentration in blood samples to be collected after drug administration		4 weeks	No
Secondary	Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement		4 weeks	Yes