A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
November 4, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: HS-20004 or placebo treatment (Low dose)
HS-20004 or placebo SC once daily (Low dose)
|
treatment
Other Names:
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Other: HS-20004 or placebo treatment (median dose 1)
HS-20004 or placebo SC once daily (median dose 1)
|
treatment
Other Names:
|
|
Other: HS-20004 or placebo treatment (median dose 2)
HS-20004 or placebo SC once daily (median dose 2)
|
treatment
Other Names:
|
|
Other: HS-20004 or placebo treatment (high dose)
HS-20004 or placebo SC once daily (high dose)
|
treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
16 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fasting Plasma Glucose
Time Frame: 16 weeks treatment
|
Estimated mean change from baseline in FPG at week 16.
|
16 weeks treatment
|
|
Change in Body Weight
Time Frame: 16 weeks treatment
|
Estimated mean change from baseline in Body Weigh at week 16.
|
16 weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2019
Primary Completion (Actual)
June 4, 2020
Study Completion (Actual)
December 14, 2020
Study Registration Dates
First Submitted
February 19, 2019
First Submitted That Met QC Criteria
February 19, 2019
First Posted (Actual)
February 21, 2019
Study Record Updates
Last Update Posted (Actual)
November 7, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-20004-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.