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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090711 | 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 or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIBA | Experimental |
| |
| Insulin Detemir | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major and Minor Hypoglycaemic Episodes | Observed 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 | Observed 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 23:00-05:59 (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 A/S | 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 |
|---|---|---|---|
| 24843632 | Result | Iwamoto Y, Clauson P, Nishida T, Kaku K. Insulin degludec in Japanese patients with type 1 diabetes mellitus: A randomized controlled trial. J Diabetes Investig. 2013 Jan 29;4(1):62-8. doi: 10.1111/j.2040-1124.2012.00240.x. Epub 2012 Sep 14. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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The period between the Visit 1 (screening visit) and Visit 2 (baseline visit) of 3 weeks [±7 days] was the run-in period. The subjects continued their insulin treatment (basal-bolus therapy: insulin glargine or neutral protamine Hagedorn (intermediate-acting insulin) [NPH] insulin) same as their pre-trial dose.
A total of 8 sites in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | SIBA | Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted. |
| FG001 | Insulin Detemir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| insulin detemir |
| Drug |
Injection subcutaneously at bedtime |
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| insulin aspart | Drug | Injection subcutaneously immediately before each meal. |
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| Week 0 to Week 6 + 5 days follow up |
| Change in Body Weight | Observed change from baseline in body weight after 6 weeks of treatment | Week 0, Week 6 |
| Electrocardiogram (ECG) | The number of subjects having a 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 Blood Pressure (BP) | Mean values at baseline (Week 0) and at Week 6 | Week 0, Week 6 |
| Systolic Blood Pressure (BP) | Mean values at baseline (Week 0) and at Week 6 | Week 0, Week 6 |
| Ebina-shi |
| 243 0432 |
| Japan |
| Novo Nordisk Investigational Site | Koriyama-shi, Fukushima | 963 8851 | Japan |
| Novo Nordisk Investigational Site | Kumamoto-shi,Kumamoto | 862 0976 | Japan |
| Novo Nordisk Investigational Site | Ōita | 870 0039 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 060 0062 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 062 0007 | Japan |
| Novo Nordisk Investigational Site | Yokohama | 235 0045 | Japan |
Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SIBA | Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted. |
| BG001 | Insulin Detemir | Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day 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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| Sex: Female, Male | 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/dL |
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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 | Observed 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 | Observed 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 23:00-05:59 (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 | Observed 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. | Posted | Mean | Standard Deviation | kg | Week 0, Week 6 |
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| Secondary | Electrocardiogram (ECG) | The number of subjects having a 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. | Posted | Number | participants | Week 0, Week 6 |
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| Secondary | Diastolic Blood Pressure (BP) | Mean values at baseline (Week 0) and at Week 6 | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | Mean | Standard Deviation | mmHg | Week 0, Week 6 |
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| Secondary | Systolic Blood Pressure (BP) | Mean values at baseline (Week 0) and at Week 6 | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. | 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 were randomised and 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 | SIBA | Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted. | 0 | 33 | 5 | 33 | ||
| EG001 | Insulin Detemir | Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted. | 0 | 32 | 2 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | 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 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
| D000069057 | Insulin Detemir |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
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