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

Sunshine Lake Pharma

Status and phase

Not yet enrolling

Phase 3

Conditions

Diabetes

Treatments

Drug: Insulin Degludec and Insulin Aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT05802862

22011-DM-301

Details and patient eligibility

About

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).

Enrollment

408 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.