NCT05802862CompletedPhase 3
A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China
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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 414 (actual)
- First submitted
- 6 Mar 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 16 Aug 2024
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05802862
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 414
- From 6 Jul 2023 to the primary completion date, 16 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunshine Lake Pharma Co., Ltd. Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.