Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05802862 | Not yet recruiting | Diabetes

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

Sunshine Lake Pharma Co., Ltd.

Brief 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).

Condition or disease

Diabetes

Intervention/treatment

Insulin Degludec and Insulin Aspart

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 408 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Multi-center, Randomized, Open, Phase III Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared Efficacy and Safety With Insulin Degludec/Insulin Aspart(Ryzodeg) in Chinese Subjects With Type 2 Diabetes
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : March 1, 2024
Arm Intervention/treatment

Experimental: 22011

Drug: Insulin Degludec and Insulin Aspart

Active Comparator: Ryzodeg

Drug: Insulin Degludec and Insulin Aspart
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations