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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination

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.