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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HMS5552 in Adult Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077452
• Other study ID #: HMM0102
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2014
• Last updated: November 17, 2017
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2017
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HMS5552

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hua Medicine Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.		up to 15 days after study drug administration
Secondary	The single dose and steady state pharmacokinetics (with food and fasting) of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2, CL/f, CLr/f, accumulation index and fluctuation index.	Single dose (Day 1) plasma and urine pharmacokinetic parameters (postprandial); Single dose (Day 3) plasma and urine pharmacokinetic parameters (fasting); Steady state (Day 7) plasma and urine pharmacokinetic parameters (postprandial); Steady state (Day 8) plasma and urine pharmacokinetic parameters (fasting)	up to day 8 post-dose
Secondary	The single dose and steady state (fasting and postprandial) pharmacodynamic variables will include maximum absolute and percent change in plasma glucose level, AUC0-4, AUC0-16, AUC16-24, AUC0-24 hr of plasma glucose.		up to 4 hour post-dose and up to 24 hour post-dose
Secondary	Insulin, C-peptide, glucagon and glucagon-like peptide 1 up to 6hr post-dose following single dose and steady state (fasting and postprandial)		up to 6 hour post-dose