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

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 Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Insulin Degludec and Insulin Aspart

• Study Type: Interventional
• Enrollment (Actual): 414
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523000
      • Sunshine Lake Pharma Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 22011	Drug: Insulin Degludec and Insulin Aspart; administered subcutaneously, once a day
Active Comparator: Ryzodeg	Drug: Insulin Degludec and Insulin Aspart; administered subcutaneously, once a day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Actual): August 16, 2024
• Study Completion (Actual): August 16, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: 22011-DM-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No