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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22011 | Experimental |
| |
| Ryzodeg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Degludec and Insulin Aspart | Drug | administered subcutaneously, once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunshine Lake Pharma Co., Ltd. | Dongguan | Guangdong | 523000 | China |
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the ratio of participant Who Achieved HbA1c<7% and ≤6.5%
| Baseline to Week24 |
| 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 |
| Change From Baseline in Fasting Plasma Glucose(FPG) | the plasma glucose concentration on an empty stomach | Baseline to Week12 |
| Change From Baseline in Fasting Plasma Glucose(FPG) in Week24 | the plasma glucose concentration on an empty stomach | Baseline to Week24 |
| 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 |
| 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 |
| Change From Baseline in Body weight | Change in body weight | Baseline to Week24 |
| Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE) | Safety | from baseline to Week25 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
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