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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HMS5552
Placebo
Sponsored by
Hua Medicine Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Glucokinase activator, Phase I, Type 2 diabetes mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    HMS5552 dose 1

    HMS5552 dose 2

    HMS5552 dose 3

    HMS5552 dose 4

    HMS5552 dose 5

    Arm Description

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 2, 2014
    Last Updated
    November 17, 2017
    Sponsor
    Hua Medicine Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02077452
    Brief Title
    Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hua Medicine Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Glucokinase activator, Phase I, Type 2 diabetes mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HMS5552 dose 1
    Arm Type
    Experimental
    Arm Description
    HMS5552 25~400mg. Oral administration, twice per day.
    Arm Title
    HMS5552 dose 2
    Arm Type
    Experimental
    Arm Description
    HMS5552 25~400mg. Oral administration, twice per day.
    Arm Title
    HMS5552 dose 3
    Arm Type
    Experimental
    Arm Description
    HMS5552 25~400mg. Oral administration, twice per day.
    Arm Title
    HMS5552 dose 4
    Arm Type
    Experimental
    Arm Description
    HMS5552 25~400mg. Oral administration, once per day.
    Arm Title
    HMS5552 dose 5
    Arm Type
    Experimental
    Arm Description
    HMS5552 25~400mg. Oral administration, twice per day.
    Intervention Type
    Drug
    Intervention Name(s)
    HMS5552
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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.
    Description
    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)
    Time Frame
    up to day 8 post-dose
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dalong ZHU, MD
    Organizational Affiliation
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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