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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: HS-20004


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HS-20004 or placebo treatment (Low dose)<br>HS-20004 or placebo SC once daily (Low dose) | Drug: HS-20004<br>* treatment<br>* Other names: Noiiglutide Injection;|
| Other: HS-20004 or placebo treatment (median dose 1)<br>HS-20004 or placebo SC once daily (median dose 1) | Drug: HS-20004<br>* treatment<br>* Other names: Noiiglutide Injection;|
| Other: HS-20004 or placebo treatment (median dose 2)<br>HS-20004 or placebo SC once daily (median dose 2) | Drug: HS-20004<br>* treatment<br>* Other names: Noiiglutide Injection;|
| Other: HS-20004 or placebo treatment (high dose)<br>HS-20004 or placebo SC once daily (high dose) | Drug: HS-20004<br>* treatment<br>* Other names: Noiiglutide Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | 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 | Estimated mean change from baseline in FPG at week 16. | 16 weeks treatment | 
| Change in Body Weight | Estimated mean change from baseline in Body Weigh at week 16. | 16 weeks treatment |