Clinical trial NCT05802862: A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12
timeFrame: Baseline to Week12
measure: Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%
timeFrame: Baseline to Week24
measure: Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes
timeFrame: Baseline to Week24
measure: Change From Baseline in Fasting Plasma Glucose(FPG)
timeFrame: Baseline to Week12
measure: Change From Baseline in Fasting Plasma Glucose(FPG) in Week24
timeFrame: Baseline to Week24
measure: Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
timeFrame: Baseline to Week12
measure: Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24
timeFrame: Baseline to Week24
measure: Change From Baseline in Body weight
timeFrame: Baseline to Week24
measure: Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)
timeFrame: from baseline to Week25
Other outcomes:
Locations:
Study officials:
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