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Completed

NCT Number: NCT03848793

A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.

The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes diagnosed for more than 3 months
  • HbA1c between 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
  • Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)

Exclusion criteria

：

  • History or family history of drug allergy
  • Subjects treated with any other anti-diabetes drug within 8 weeks before screening
  • Participation in any other clinical trial of an investigational medicinal product within 3 months before screening
  • Smoker or alcohol abuse
  • Currently use or plan to use systemic corticosteroid
  • History of recurrent severe hypoglycemia
  • Type 1 diabetes or secondary diabetes mellitus
  • Uncontrolled active or untreated hypertension
  • History of pancreatitis (acute or chronic)
  • Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
  • Serious unconscious hypoglycemia history
  • Within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in New York Heart Association (NYHA) Class III or IV, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias
  • Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control
  • Subject was not used for the study as determined by the Investigator

Treatment and study plan

HS-20004

Drug

treatment

Other names: Noiiglutide Injection

Primary outcomes

  1. HbA1c

    Time frame: 16 weeks treatment

    Estimated mean change from baseline in HbA1c at week 16. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product

Secondary outcomes

  1. Change in Fasting Plasma Glucose

    Time frame: 16 weeks treatment

    Estimated mean change from baseline in FPG at week 16.

  2. Change in Body Weight

    Time frame: 16 weeks treatment

    Estimated mean change from baseline in Body Weigh at week 16.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Multiple Centers, Double-blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
Nov 7, 2022

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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