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

Primary Purpose

Diabetes

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Insulin Degludec and Insulin Aspart
Sponsored by
Sunshine Lake Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    22011

    Ryzodeg

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Hemoglobin A1c (HbA1c)
    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time

    Secondary Outcome Measures

    Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12
    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
    Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%
    the ratio of participant Who Achieved HbA1c<7% and ≤6.5%
    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
    Change From Baseline in Fasting Plasma Glucose(FPG)
    the plasma glucose concentration on an empty stomach
    Change From Baseline in Fasting Plasma Glucose(FPG) in Week24
    the plasma glucose concentration on an empty stomach
    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.
    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.
    Change From Baseline in Body weight
    Change in body weight
    Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)
    Safety

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    April 4, 2023
    Sponsor
    Sunshine Lake Pharma Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05802862
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sunshine Lake Pharma Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    408 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    22011
    Arm Type
    Experimental
    Arm Title
    Ryzodeg
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Degludec and Insulin Aspart
    Intervention Description
    administered subcutaneously, once a day
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hemoglobin A1c (HbA1c)
    Description
    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
    Time Frame
    Baseline to Week 24
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12
    Description
    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
    Time Frame
    Baseline to Week12
    Title
    Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%
    Description
    the ratio of participant Who Achieved HbA1c<7% and ≤6.5%
    Time Frame
    Baseline to Week24
    Title
    Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes
    Description
    The ratio of participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes
    Time Frame
    Baseline to Week24
    Title
    Change From Baseline in Fasting Plasma Glucose(FPG)
    Description
    the plasma glucose concentration on an empty stomach
    Time Frame
    Baseline to Week12
    Title
    Change From Baseline in Fasting Plasma Glucose(FPG) in Week24
    Description
    the plasma glucose concentration on an empty stomach
    Time Frame
    Baseline to Week24
    Title
    Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
    Description
    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.
    Time Frame
    Baseline to Week12
    Title
    Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24
    Description
    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.
    Time Frame
    Baseline to Week24
    Title
    Change From Baseline in Body weight
    Description
    Change in body weight
    Time Frame
    Baseline to Week24
    Title
    Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE)
    Description
    Safety
    Time Frame
    from baseline to Week25

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Linong Ji, Doctor
    Phone
    010-88326666
    Email
    jiln@bjmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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