A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China

Launched by SUNSHINE LAKE PHARMA CO., LTD. · Apr 4, 2023

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Eligibility criteria

• Inclusion Criteria:
• • Informed consent obtained before any trial-related activities.
• • Male or female, age at least 18 year-old and no more than 75 year-old at the time of signing informed consent.
• • Type 2 diabetes mellitus (T2D).
• • Body mass index (BMI) higher than 18.0, but below or equal to 35.0 kg/m\^2.
• • Current treatment for at least 3 months prior to screening with basal insulin/premixed insulin once a day or twice a day with/without oral anti-diabetic drugs (OADs): metformin, alpha-glucosidase inhibitors, dimethylphenylpenicillin dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-dependent glucose transporter 2 (SGLT-2) inhibitors . For above or equal to 3 months prior to screening subjects should be on a stable dose.
• • HbA1c from 7-11.0% both inclusive at screening confirmed by central laboratory analysis.
• Exclusion Criteria:
• • Have a diagnosis of type 1 diabetes (T1D), or specific type of diabetes other than T2D, for example, injured pancreas, diseases of acromegaly-induced diabetes.
• • Have a history of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
• • Have had severe hypoglycemia episodes within 6 months prior to screening.