DiabetesPhase 3NCT05802862
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 Phase 3 study testing Insulin Degludec and Insulin Aspart in people with Diabetes, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Insulin Degludec and Insulin Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2023to 16 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Diabetes
- Being tested
- Insulin Degludec and Insulin Aspart
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Degludec and Insulin AspartDrug
administered subcutaneously, once a day
| Study group | Role | What they receive |
|---|---|---|
| 22011 | Experimental | Not described Receives: Drug: Insulin Degludec and Insulin Aspart |
| Ryzodeg | Active comparator | Not described Receives: Drug: Insulin Degludec and Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
Measured: Baseline to Week 24
Secondary outcomes (9)
Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
Measured: Baseline to Week12
Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%
the ratio of participant Who Achieved HbA1c<7% and ≤6.5%
Measured: Baseline to Week24
Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes
The ratio of participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes
Measured: Baseline to Week24
Change From Baseline in Fasting Plasma Glucose(FPG)
the plasma glucose concentration on an empty stomach
Measured: Baseline to Week12
Change From Baseline in Fasting Plasma Glucose(FPG) in Week24
the plasma glucose concentration on an empty stomach
Measured: Baseline to Week24
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
SMBG 7-point profiles were measured at fasting, 2-hour post morning meal, pre midday meal, 2-hour post midday meal, pre evening meal, 2-hours post evening meal, and bedtime.
Measured: Baseline to Week12
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24
SMBG 7-point profiles were measured at fasting, 2-hour post morning meal, pre midday meal, 2-hour post midday meal, pre evening meal, 2-hours post evening meal, and bedtime.
Measured: Baseline to Week24
Change From Baseline in Body weight
Change in body weight
Measured: Baseline to Week24
Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)
Safety
Measured: from baseline to Week25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start6 Jul 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802862
- Sponsor's protocol ID
- 22011-DM-301
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05802862
- Acronym / sponsor ID
- 22011-DM-301
- Conditions
- Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22011 | Experimental | Drug: Insulin Degludec and Insulin Aspart |
| Ryzodeg | Active comparator | Drug: Insulin Degludec and Insulin Aspart |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Degludec and Insulin Aspartadministered subcutaneously, once a day | Drug | 22011, Ryzodeg |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 24
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
9 secondary outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12
Time frame: Baseline to Week12
Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%
Time frame: Baseline to Week24
Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes
Time frame: Baseline to Week24
Change From Baseline in Fasting Plasma Glucose(FPG)
Time frame: Baseline to Week12
Change From Baseline in Fasting Plasma Glucose(FPG) in Week24
Time frame: Baseline to Week24
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Time frame: Baseline to Week12
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24
Time frame: Baseline to Week24
Change From Baseline in Body weight
Time frame: Baseline to Week24
Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)
Time frame: from baseline to Week25
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Degludec and Insulin Aspart in people with Diabetes, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.