Skip to main content
OpenTrials
Completed

NCT Number: NCT02077452

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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:

  • To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes
  • To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HMS5552

Drug

Placebo

Drug

Primary outcomes

  1. Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.

    Time frame: up to 15 days after study drug administration

Secondary outcomes

  1. 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.

    Time frame: up to day 8 post-dose

    • 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)

  2. 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.

    Time frame: up to 4 hour post-dose and up to 24 hour post-dose

  3. Insulin, C-peptide, glucagon and glucagon-like peptide 1 up to 6hr post-dose following single dose and steady state (fasting and postprandial)

    Time frame: up to 6 hour post-dose

Sponsors and collaborators

Lead sponsor

Hua Medicine Limited

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2014
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.