Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02386982

Enrollment

Registered

2015-03-12

Start date

2015-03-31

Completion date

2015-05-31

Last updated

2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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

Interventions

DRUGHMS5552

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
beta cell function	4 weeks	will be assessed by change of beta cell function index
HbA1	4 weeks	—
24-hour glucose change	4 weeks	—

Secondary

Measure	Time frame
The study drug concentration in blood samples to be collected after drug administration	4 weeks
Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement	4 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026