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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090712 | Registry Identifier | JAPIC |
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This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mix30 | Active Comparator |
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| SIAC | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major and Minor Hypoglycaemic Episodes | Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. | Week 0 to Week 6 + 5 days follow up |
| Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive). | Week 0 to Week 6 + 5 days follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (AEs) | Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk Pharma Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Chuo-ku, Tokyo | 103 0002 | Japan | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27560769 | Result | Onishi Y, Yamada K, Zacho J, Ekelund J, Iwamoto Y. Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial. J Diabetes Investig. 2017 Mar;8(2):210-217. doi: 10.1111/jdi.12569. Epub 2016 Oct 7. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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A total of 8 sites in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | SIAC | Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| biphasic insulin aspart 30 | Drug | The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner. |
|
| Week 0 to Week 6 + 5 days follow up |
| Change in Body Weight | Change from baseline in body weight after 6 weeks of treatment | Week 0, Week 6 |
| Electrocardiogram (ECG) Worsening | The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. | Week 0, Week 6 |
| Diastolic BP (Blood Pressure) | Values at baseline (Week 0) and at Week 6 | Week 0, Week 6 |
| Systolic BP (Blood Pressure) | Values at baseline (Week 0) and at Week 6 | Week 0, Week 6. |
| Miyazaki |
| 880 0034 |
| Japan |
| Novo Nordisk Investigational Site | Naka-shi, Ibaraki | 311 0113 | Japan |
| Novo Nordisk Investigational Site | Ota-ku, Tokyo | 144 0035 | Japan |
| Novo Nordisk Investigational Site | Oyama-shi, Tochigi | 323 0022 | Japan |
| Novo Nordisk Investigational Site | Sendai | 980 0021 | Japan |
| Novo Nordisk Investigational Site | Shizuoka | 424 0853 | Japan |
| Novo Nordisk Investigational Site | Tagajō-shi | 985 0852 | Japan |
| Mix30 |
Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SIAC | Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted |
| BG001 | Mix30 | Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mg/L |
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| Body weight | Mean | Standard Deviation | kg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Major and Minor Hypoglycaemic Episodes | Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | Episodes /year of patient exposure | Week 0 to Week 6 + 5 days follow up |
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| Primary | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive). | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | Episodes /year of patient exposure | Week 0 to Week 6 + 5 days follow up |
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| Secondary | Number of Treatment Emergent Adverse Events (AEs) | Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | Number | events | Week 0 to Week 6 + 5 days follow up |
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| Secondary | Change in Body Weight | Change from baseline in body weight after 6 weeks of treatment | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | kg | Week 0, Week 6 |
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| Secondary | Electrocardiogram (ECG) Worsening | The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). | Posted | Number | participants | Week 0, Week 6 |
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| Secondary | Diastolic BP (Blood Pressure) | Values at baseline (Week 0) and at Week 6 | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | mmHg | Week 0, Week 6 |
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| Secondary | Systolic BP (Blood Pressure) | Values at baseline (Week 0) and at Week 6 | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | mmHg | Week 0, Week 6. |
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The adverse events were collected in a time frame of 6 weeks + 5 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SIAC | Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted | 1 | 33 | 5 | 33 | ||
| EG001 | Mix30 | Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted. | 0 | 32 | 3 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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