Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes

Korábbi kezelés

• Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening,
• Presence or history of pancreatitis (acute or chronic) within 180 days before screening,
• Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
  • Chronic heart failure classified as being in New York Heart Association Class IV at screening,
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.

Laborértékek

• Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids),

Egyéb

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method,

• Male or female, age reach and over 18 years at the time of signing informed consent,
• Body mass index (BMI) between 18.0 and 35.0 kg/m\^2 (both inclusive),
• Type 2 diabetes mellitus (as diagnosed clinically) before screening.
• hemoglobin A1c of 7.5 - 9.0% (both inclusive) as assessed by central laboratory on the day of screening,
• Treated with stable doses of oral antidiabetic drugs (OADs) , insulin or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide, etc.) within 3 months prior to screening;