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

NCT05802862 | Completed Phase 3

• 1 other identifier: 22011-DM-301
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12

  Baseline to Week12

• Percentage 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

  Baseline to Week24

• Change From Baseline in Fasting Plasma Glucose(FPG)

  Baseline to Week12

• Change From Baseline in Fasting Plasma Glucose(FPG) in Week24

  Baseline to Week24

Study Arms (2)

22011

EXPERIMENTAL

Drug: Insulin Degludec and Insulin Aspart

Ryzodeg

ACTIVE COMPARATOR

Drug: Insulin Degludec and Insulin Aspart

Interventions

Insulin Degludec and Insulin Aspart DRUG

administered subcutaneously, once a day

22011; Ryzodeg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Sunshine Lake Pharma Co., Ltd.

Dongguan, Guangdong, 523000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec, insulin aspart drug combination

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 7, 2023
• Study Start: July 6, 2023
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: May 1, 2026

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)