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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: HS-20004

Study type: Interventional

Funder types: Industry

Identifiers

NCT03848793

HS-20004-201

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups

HS-20004 or placebo treatment (Low dose)

Other group

Description:

HS-20004 or placebo SC once daily (Low dose)

Treatment:

Drug: HS-20004

HS-20004 or placebo treatment (median dose 1)

Other group

Description:

HS-20004 or placebo SC once daily (median dose 1)

Treatment:

Drug: HS-20004

HS-20004 or placebo treatment (median dose 2)

Other group

Description:

HS-20004 or placebo SC once daily (median dose 2)

Treatment:

Drug: HS-20004

HS-20004 or placebo treatment (high dose)

Other group

Description:

HS-20004 or placebo SC once daily (high dose)

Treatment:

Drug: HS-20004