Diabetes
Conditions
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).
Interventions
administered subcutaneously, once a day
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) | Baseline to Week12 | the plasma glucose concentration on an empty stomach |
| 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 | 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 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. |
| Change From Baseline in Body weight | Baseline to Week24 | Change in body weight |
| Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE) | from baseline to Week25 | Safety |
Countries
China
Outcome results
None listed