A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China
- Conditions
- Diabetes
- Interventions
- Drug: Insulin Degludec and Insulin Aspart
- Registration Number
- NCT05802862
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 408
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 22011 Insulin Degludec and Insulin Aspart - Ryzodeg Insulin Degludec and Insulin Aspart -
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline to Week 24 HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
- Secondary Outcome Measures
Name Time Method Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% Baseline to Week24 the ratio of participant Who Achieved HbA1c\<7% and ≤6.5%
Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes Baseline to Week24 The ratio of participant Who Achieved HbA1c\<7% and ≤6.5% without Hypoglycaemic Episodes
Change From Baseline in Fasting Plasma Glucose(FPG) in Week24 Baseline to Week24 the plasma glucose concentration on an empty stomach
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24 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.
Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE) from baseline to Week25 Safety
Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12 Baseline to Week12 HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
Change From Baseline in Fasting Plasma Glucose(FPG) Baseline to Week12 the plasma glucose concentration on an empty stomach
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values 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.
Change From Baseline in Body weight Baseline to Week24 Change in body weight