Phase
Condition
Diabetic Gastroparesis
Diabetes Prevention
Diabetic Foot Ulcers
Treatment
Insulin Degludec
GZR4
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female at the age of 18-65 (inclusive) at the time of informed consent
Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
Diagnosis of type 2 diabetes mellitus for over 3 months
Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.
Exclusion
Exclusion Criteria:
History of drug abuse within 1 year before screening, or positive drug abusescreening results during the screening period or at baseline
Malignancy or increased risk of malignancy before screening: any suspected and/ordiagnosed malignancy or documented history of malignancy
Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, orspecific types of diabetes mellitus from other causes (monogenic diabetes syndrome,cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus,etc.) prior to screening
Presence of the following diseases within 6 months prior to screening: diabeticketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma;proliferative retinopathy or maculopathy that is unstable or requiring treatment;symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior toscreening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1month prior to screening, or recurrent hypoglycaemia-related symptoms
Study Design
Connect with a study center
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing 100000
ChinaSite Not Available
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