Skip to main content
OpenTrials
Completed

NCT Number: 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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sunshine Lake Pharma Co., Ltd.

Dongguan, Guangdong, 523000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Degludec and Insulin Aspart

Drug

administered subcutaneously, once a day

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline to Week 24

    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time

Secondary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12

    Time frame: Baseline to Week12

    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time

  2. Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%

    Time frame: Baseline to Week24

    the ratio of participant Who Achieved HbA1c<7% and ≤6.5%

  3. Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes

    Time frame: Baseline to Week24

    The ratio of participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes

  4. Change From Baseline in Fasting Plasma Glucose(FPG)

    Time frame: Baseline to Week12

    the plasma glucose concentration on an empty stomach

  5. Change From Baseline in Fasting Plasma Glucose(FPG) in Week24

    Time frame: Baseline to Week24

    the plasma glucose concentration on an empty stomach

  6. Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values

    Time frame: Baseline to Week12

    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.

  7. Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24

    Time frame: Baseline to 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.

  8. Change From Baseline in Body weight

    Time frame: Baseline to Week24

    Change in body weight

  9. Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)

    Time frame: from baseline to Week25

    Safety

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.