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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03848793

Enrollment

128

Registered

2019-02-21

Start date

2019-03-06

Completion date

2020-12-14

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGHS-20004

treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026