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

• Status: Unknown status
• Trial end date: 2020-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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