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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: HS-20004

• Registration Number: NCT03848793
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-03-06
• Primary Completion: 2020-06-04
• Study Completion: 2020-12-14
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS-20004 or placebo treatment (Low dose)	HS-20004	HS-20004 or placebo SC once daily (Low dose)
HS-20004 or placebo treatment (median dose 1)	HS-20004	HS-20004 or placebo SC once daily (median dose 1)
HS-20004 or placebo treatment (median dose 2)	HS-20004	HS-20004 or placebo SC once daily (median dose 2)
HS-20004 or placebo treatment (high dose)	HS-20004	HS-20004 or placebo SC once daily (high dose)

Primary Outcome Measures

Name	Time	Method
HbA1c	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

Name	Time	Method
Change in Fasting Plasma Glucose	16 weeks treatment	Estimated mean change from baseline in FPG at week 16.
Change in Body Weight	16 weeks treatment	Estimated mean change from baseline in Body Weigh at week 16.

Trial Locations

Locations (1)

Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China