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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1205-1788 | Other Identifier | World Health Organization (WHO) |
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The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. This is to give participants insulin automatically. The CGM device is already available for sale. The iLet™ is not yet approved for use. Fast-acting insulin aspart is a type of insulin that doctors can already prescribe for use with insulin pens, but not for use in an insulin pump. This study is to test how safe fast acting insulin aspart is when used with different insulin delivery settings in the iLet™ in people with type 1 diabetes. Participants will get fast-acting insulin aspart as participants' insulin and use the iLet™ as participants' insulin pump with a CGM device. Participants' iLet™ will be set to 2 different insulin delivery settings for 7 days on each setting. The setting participants get first is decided by chance. The study will last for about 5 to 9 weeks. Participants will have 4 visits and 1 phone contact with the study or staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-acting insulin aspart, default tmax setting | Experimental | Participants will receive fast-acting insulin aspart using the iLet™ with default tmax setting (t65 = 65 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort. |
|
| Fast-acting insulin aspart, non-default tmax setting | Experimental | Participants will receive fast-acting insulin aspart using the iLet™ with non-default tmax setting (t50 = 50 minutes, t40 = 40 minutes or t30 = 30 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast-acting insulin aspart | Drug | In each cohort, participants will receive fast-acting insulin aspart using the iLet™ in a cross-over manner for 14 days (7days per period). Dose modification will be handled autonomously by the iLet™ based on the CGM sensor readings and the user interaction with the iLet™ e.g. meal announcements. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) | Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold. | Day 1 to day 7 |
| Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median | Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold. | Day 1 to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Severe Hypoglycaemic Episodes | Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34146238 | Derived | Russell SJ, Balliro C, Ekelund M, El-Khatib F, Graungaard T, Greaux E, Hillard M, Jafri RZ, Rathor N, Selagamsetty R, Sherwood J, Damiano ER. Improvements in Glycemic Control Achieved by Altering the tmax Setting in the iLet(R) Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial. Diabetes Ther. 2021 Jul;12(7):2019-2033. doi: 10.1007/s13300-021-01087-x. Epub 2021 Jun 19. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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The trial was conducted at one site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: t65 First, Then t50 | iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. The total treatment duration for each cohort was 14 days. |
| FG001 | Cohort 1: t50 First, Then t65 | iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days. |
| FG002 | Cohort 2: t65 First, Then t40 | iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. The total treatment duration for each cohort was 14 days. |
| FG003 | Cohort 2: t40 First, Then t65 | iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days. |
| FG004 | Cohort 3: t65 First, Then t30 | iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. The total treatment duration for each cohort was 14 days. |
| FG005 | Cohort 3: t30 First, Then t65 | iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for each cohort was 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Period (7 Days) |
|
| ||||||||||||||||||
| Second Treatment Period (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) | Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold. | Full analysis set: included all randomised subjects receiving treatment.Number of participants analysed=participants with available data. | Posted | Mean | Standard Deviation | Percentage | Day 1 to day 7 |
|
From the first trial-related activity (screening, day -14) after obtaining informed consent and until the follow up visit (treatment days 7 in both periiods+7 days follow-up)
All adverse events listed are treatment emergent. Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.
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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 | t50 Faster Aspart Cohort 1 | Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t50 = 50 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2019 | Apr 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
|
| iLet™ | Device | The bionic pancreas including pigtail adapters, used in insulin-only configuration |
|
| Day 1 to day 7 |
| Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day | Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment. | Day 1 to day 7 |
| Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition | ADA classification of hypoglycaemia:
| Day 1 to day 7 |
| Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification | Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
| Day 1 to day 7 |
| Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition | ADA classification of hypoglycaemia:
| Day 1 to day 7 (in both the treatment periods) |
| Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification | Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
| Day 1 to day 7 |
| Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition | ADA classification of hypoglycaemia:
| Day 1 to day 7 |
| Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification | Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
| Day 1 to day 7 (in both the treatment periods) |
| Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages) | Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold. | Day 1 to day 7 |
| Mean Interstitial-glucose Level | Mean interstitial glucose level is calculated as the average of the available interstitial glucose values. | Day 1 to day 7 |
| Number of Treatment Emergent Adverse Events | Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment. | Day 1 to day 7 |
| Number of Treatment Emergent Infusion Site Reactions | Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment. | Day 1 to day 7 |
| Total Insulin Dose Per Day | Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days. | Day 1 to day 7 |
| COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Cohort 2 | Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
| BG002 | Cohort 3 | Participants were randomised in a 1:1 manner to one of two treatment sequences. First sequence: Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. Second sequence: Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) for 7 days. After 7 days they received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) for 7 days. The total treatment duration for the cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | t65 Faster Aspart Cohort 1 | Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
| OG002 | t40 Faster Aspart Cohort 2 | Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
| OG003 | t65 Faster Aspart Cohort 2 | Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
| OG004 | t30 Faster Aspart Cohort 3 | Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
| OG005 | t65 Faster Aspart Cohort 3 | Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. |
|
|
| Primary | Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median | Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL [3 mmol/L]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold. | Full analysis set: included all randomised subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Median | Full Range | Percentage | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Severe Hypoglycaemic Episodes | Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. | Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Episodes | Day 1 to day 7 |
|
|
|
| Secondary | Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day | Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment. | Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Mean | Standard Deviation | Episodes | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition | ADA classification of hypoglycaemia:
| Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Episodes | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification | Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
| Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Episodes | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition | ADA classification of hypoglycaemia:
| Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Episodes | Day 1 to day 7 (in both the treatment periods) |
|
|
|
| Secondary | Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification | Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
| Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Episodes | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition | ADA classification of hypoglycaemia:
| Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Episodes | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification | Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia:
| Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Episodes | Day 1 to day 7 (in both the treatment periods) |
|
|
|
| Secondary | Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages) | Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold. | Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Mean | Standard Deviation | Percentage | Day 1 to day 7 |
|
|
|
| Secondary | Mean Interstitial-glucose Level | Mean interstitial glucose level is calculated as the average of the available interstitial glucose values. | Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Mean | Standard Deviation | mg/dL | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Adverse Events | Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment. | Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Events | Day 1 to day 7 |
|
|
|
| Secondary | Number of Treatment Emergent Infusion Site Reactions | Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment. | Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Number | Infusion site reaction | Day 1 to day 7 |
|
|
|
| Secondary | Total Insulin Dose Per Day | Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days. | Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data. | Posted | Mean | Standard Deviation | U/Kg/day | Day 1 to day 7 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | t65 Faster Aspart Cohort 1 | Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 1. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG002 | t40 Faster Aspart Cohort 2 | Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t40 = 40 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | t65 Faster Aspart Cohort 2 | Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 2. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG004 | t30 Faster Aspart Cohort 3 | Participants received fast-acting insulin aspart with the iLet™ having non-default tmax in the algorithm settings (t30 = 30 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | t65 Faster Aspart Cohort 3 | Participants received fast-acting insulin aspart with the iLet™ having default tmax in the algorithm settings (t65 = 65 minutes) in cohort 3. The total treatment duration for each cohort was 14 days with each cross-over period of the 2 tmax settings being 7 days. | 0 | 7 | 0 | 7 | 1 | 7 |
| Infusion site reaction | General disorders | MedDRA 22 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Documented symptomatic hypoglycaemia |
|
| Asymptomatic hypoglycaemia |
|
| Probable symptomatic hypoglycaemia |
|
| Pseudo-hypoglycaemia |
|
| Symptomatic BG confirmed hypoglycaemia |
|
| Asymptomatic BG confirmed hypoglycaemia |
|
| BG confirmed hypoglycaemia |
|
| Severe or BG confirmed symptomatic hypoglycaemia |
|
| Severe or BG confirmed hypoglycaemia |
|
| Documented symptomatic hypoglycaemia |
|
| Asymptomatic hypoglycaemia |
|
| Probable symptomatic hypoglycaemia |
|
| Pseudo-hypoglycaemia |
|
| Symptomatic BG confirmed hypoglycaemia |
|
| Asymptomatic BG confirmed hypoglycaemia |
|
| BG confirmed hypoglycaemia |
|
| Severe or BG confirmed symptomatic hypoglycaemia |
|
| Severe or BG confirmed hypoglycaemia |
|
| Documented symptomatic hypoglycaemia |
|
| Asymptomatic hypoglycaemia |
|
| Probable symptomatic hypoglycaemia |
|
| Pseudo-hypoglycaemia |
|
| Symptomatic BG confirmed hypoglycaemia |
|
| Asymptomatic BG confirmed hypoglycaemia |
|
| BG confirmed hypoglycaemia |
|
| Severe or BG confirmed symptomatic hypoglycaemia |
|
| Severe or BG confirmed hypoglycaemia |
|