Status:
COMPLETED
A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03848793
Start Date
March 6 2019
End Date
December 14 2020
Last Update
November 7 2022
Active Locations (1)
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1
Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008