Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

Hua Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: HMS5552

Study type: Interventional

Funder types: Industry

Identifiers

NCT02386982

HMM0103

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

HMS5552 dose 1

Experimental group

Description:

HMS5552 75mg.Oral administration,twice per day.

Treatment:

Drug: HMS5552

HMS5552 dose 2

Experimental group

Description:

HMS5552 75mg.Oral administration,once per day.

Treatment:

Drug: HMS5552