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

NCT02077452 | Completed Phase 1

• 1 other identifier: HMM0102
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Glucokinase activator; Phase I; Type 2 diabetes mellitus

Outcome Measures

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.

  up to 15 days after study drug administration

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (5)

HMS5552 dose 1

EXPERIMENTAL

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

Drug: HMS5552; Drug: Placebo

HMS5552 dose 2

EXPERIMENTAL

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

Drug: HMS5552; Drug: Placebo

HMS5552 dose 3

EXPERIMENTAL

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

Drug: HMS5552; Drug: Placebo

HMS5552 dose 4

EXPERIMENTAL

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

Drug: HMS5552; Drug: Placebo

HMS5552 dose 5

EXPERIMENTAL

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

Drug: HMS5552; Drug: Placebo

Interventions

HMS5552 DRUG

HMS5552 dose 1; HMS5552 dose 2; HMS5552 dose 3; HMS5552 dose 4; HMS5552 dose 5

Placebo DRUG

HMS5552 dose 1; HMS5552 dose 2; HMS5552 dose 3; HMS5552 dose 4; HMS5552 dose 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hua Medicine Limited: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dalong ZHU, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 20, 2017

Record last verified: 2017-11