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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05802862
• Other study ID #: 22011-DM-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2023
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: Linong Ji, Doctor
• Phone: 010-88326666
• Email: jiln[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 408
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• Insulin Degludec and Insulin Aspart
administered subcutaneously, once a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of Participant Who Achieved HbA1c<7% and =6.5%	the ratio of participant Who Achieved HbA1c<7% and =6.5%	Baseline to Week24
Secondary	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
Secondary	Change From Baseline in Fasting Plasma Glucose(FPG)	the plasma glucose concentration on an empty stomach	Baseline to Week12
Secondary	Change From Baseline in Fasting Plasma Glucose(FPG) in Week24	the plasma glucose concentration on an empty stomach	Baseline to Week24
Secondary	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
Secondary	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
Secondary	Change From Baseline in Body weight	Change in body weight	Baseline to Week24
Secondary	Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)	Safety	from baseline to Week25