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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Insulin Degludec and Insulin Aspart


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 22011<br> | Drug: Insulin Degludec and Insulin Aspart<br>* administered subcutaneously, once a day<br>|
| Active Comparator: Ryzodeg<br> | Drug: Insulin Degludec and Insulin Aspart<br>* administered subcutaneously, once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12 | HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time | Baseline to Week12 | 
| Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% | the ratio of participant Who Achieved HbA1c<7% and ≤6.5% | 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 | Baseline to Week24 | 
| Change From Baseline in Fasting Plasma Glucose(FPG) | the plasma glucose concentration on an empty stomach | Baseline to Week12 | 
| Change From Baseline in Fasting Plasma Glucose(FPG) in Week24 | the plasma glucose concentration on an empty stomach | 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. | 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. | Baseline to Week24 | 
| Change From Baseline in Body weight | Change in body weight | Baseline to Week24 | 
| Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE) | Safety | from baseline to Week25 |