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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03848793
Recruitment Status : Unknown
Verified February 2019 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: HS-20004 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
HS-20004 or placebo treatment (Low dose)
HS-20004 or placebo SC once daily (Low dose)
 Drug: HS-20004
treatment
Other Name: Noiiglutide Injection
HS-20004 or placebo treatment (median dose 1)
HS-20004 or placebo SC once daily (median dose 1)
 Drug: HS-20004
treatment
Other Name: Noiiglutide Injection
HS-20004 or placebo treatment (median dose 2)
HS-20004 or placebo SC once daily (median dose 2)
 Drug: HS-20004
treatment
Other Name: Noiiglutide Injection
HS-20004 or placebo treatment (high dose)
HS-20004 or placebo SC once daily (high dose)
 Drug: HS-20004
treatment
Other Name: Noiiglutide Injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848793


Contacts
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Contact: JIE WU +868936619898 wujie@hrglobe.cn
Contact: AN PEI +8618036617508 anpei@hrglobe.cn

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03848793    
Other Study ID Numbers: HS-20004-201
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases