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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848793
• Other study ID #: HS-20004-201
• Status: Completed
• Phase: Phase 2
• Start date: March 6, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: November 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 14, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• HS-20004
treatment

Locations

Country	Name	City	State
China	Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Fasting Plasma Glucose	Estimated mean change from baseline in FPG at week 16.	16 weeks treatment
Secondary	Change in Body Weight	Estimated mean change from baseline in Body Weigh at week 16.	16 weeks treatment