Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes

Hua Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: HMS5552; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02077452

HMM0102

Details and patient eligibility

About

The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.

Full description

This will be a randomized, double-blind and placebo-controlled study with multiple oral doses of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before.

The primary objective is to characterize the safety and tolerability of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8 days.

The secondary objectives include:

1. To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes
2. To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes
3. To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics

A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5~8 dose levels). There will be 8 active and 2 placebo patients in each dose group. The safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects with type 2 diabetes
• Age: 18 to 65 years
• BMI: 20 to 29 kg/m2
• Mentally, physically and legally eligible to give informed consent.
• Willingness to adhere to the protocol requirement.

Exclusion criteria

• Subjects with type 1 diabetes
• Episodes of hypoglycemia
• Unstable cardiovascular diseases
• Hepatic diseases
• Kidney disease
• Mental or central nervous system diseases
• Clinical abnormal findings in ECG, labs and physical exams

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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53 participants in 5 patient groups

HMS5552 dose 1

Experimental group

Description:

HMS5552 25\~400mg. Oral administration, twice per day.

Treatment:

Drug: Placebo

Drug: HMS5552

HMS5552 dose 2

Experimental group

Description:

HMS5552 25\~400mg. Oral administration, twice per day.

Treatment:

Drug: Placebo

Drug: HMS5552

HMS5552 dose 3

Experimental group

Description:

HMS5552 25\~400mg. Oral administration, twice per day.

Treatment:

Drug: Placebo

Drug: HMS5552

HMS5552 dose 4

Experimental group

Description:

HMS5552 25\~400mg. Oral administration, once per day.

Treatment:

Drug: Placebo

Drug: HMS5552

HMS5552 dose 5

Experimental group

Description:

HMS5552 25\~400mg. Oral administration, twice per day.

Treatment:

Drug: Placebo

Drug: HMS5552