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Completed

NCT Number: NCT02386982

Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.

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Key information

Conditions

Type 2 Diabetes 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

Primary location

The 1st Betuhune Hospital of Jilin University

Changchun, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female,age 18-65 years
  • Has type 2 diabetes mellitus
  • BMI 20 to 29kg/m2
  • Willingness to adhere to the protocol requirement

Exclusion criteria

  • Patients with type1 diabetes mellitus
  • Received any antidiabetic drug within run-in or during screening
  • Hepatic diseases
  • Kidney diseases
  • Clinical abnormal finding in EVG,labs and physical exams
  • Women of child-bearing potential

Treatment and study plan

HMS5552

Drug

Other names: Sinogliatin

Primary outcomes

  1. beta cell function

    Time frame: 4 weeks

    will be assessed by change of beta cell function index

  2. HbA1

    Time frame: 4 weeks

  3. 24-hour glucose change

    Time frame: 4 weeks

Secondary outcomes

  1. The study drug concentration in blood samples to be collected after drug administration

    Time frame: 4 weeks

  2. Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Hua Medicine Limited

Industry

Registry information

Official study title

A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2015
Registry last updated
May 14, 2015

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.

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