Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Diabetes Prevention
Treatment
Insulin Degludec
GZR4 Injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
Diagnosed with type 2 diabetes mellitus above or equal to 6 months
7.5% ≤ HbA1c ≤ 10.0% at screening.
Exclusion
Exclusion Criteria:
Female who is pregnant, breast-feeding.
Presence or history of malignant neoplasm prior to screening.
Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolarsyndrome within 6 months prior to screening.
Known or suspected hypersensitivity to investigational medical product(s) or relatedproducts.
Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening
History of acute heart failure within 6 months prior to screening or hospitalizationfor coronary heart disease, myocardial infarction, unstable angina, stroke within 6months prior to screening.
Participation in a clinical study of another study drug within 3 month prior torandomization.
Study Design
Connect with a study center
Study Site 07
Wuhan, Hubei
ChinaSite Not Available
Study Site 06
Changzhou, Jiangsu
ChinaSite Not Available
Study Site 08
Jinan, Shandong
ChinaSite Not Available
Study Site 04
Zibo, Shandong
ChinaSite Not Available
Study Site 03
Xi'an, Shanxi
ChinaSite Not Available
Study Site 02
Beijing,
ChinaSite Not Available
Study Site 05
Beijing,
ChinaSite Not Available
Study Site 01
Tianjin,
ChinaSite Not Available

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