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

Sponsor
Hua Medicine Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02077452
Collaborator
(none)
53
Enrollment
5
Arms
7
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: HMS5552 dose 1

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

Drug: HMS5552

Drug: Placebo
Experimental: HMS5552 dose 2

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

Drug: HMS5552

Drug: Placebo
Experimental: HMS5552 dose 3

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

Drug: HMS5552

Drug: Placebo
Experimental: HMS5552 dose 4

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

Drug: HMS5552

Drug: Placebo
Experimental: HMS5552 dose 5

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

Drug: HMS5552

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  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. [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. [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) [up to 6 hour post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hua Medicine Limited

Investigators

  • Principal Investigator: Dalong ZHU, MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hua Medicine Limited
ClinicalTrials.gov Identifier:
NCT02077452
Other Study ID Numbers:
  • HMM0102
First Posted:
Mar 4, 2014
Last Update Posted:
Nov 20, 2017
Last Verified:
Nov 1, 2017
Keywords provided by Hua Medicine Limited
Glucokinase activator
Phase I
Type 2 diabetes mellitus
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 20, 2017