Trial Outcomes & Findings for Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes (NCT NCT03816761)
NCT ID: NCT03816761
Last Updated: 2020-06-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Day 1 to day 7
Results posted on
2020-06-11
Participant Flow
The trial was conducted at one site in the United States.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
First Treatment Period (7 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
First Treatment Period (7 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
First Treatment Period (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Second Treatment Period (7 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Second Treatment Period (7 Days)
COMPLETED
|
4
|
4
|
4
|
3
|
4
|
3
|
|
Second Treatment Period (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
First Treatment Period (7 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Second Treatment Period (7 Days)
Unclassified
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
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.
|
Cohort 2
n=8 Participants
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.
|
Cohort 3
n=8 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.5 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
36.3 Years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
47.1 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
43.0 Years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to day 7Population: Full analysis set: included all randomised subjects receiving treatment.Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
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)
|
0.98 Percentage
Standard Deviation 0.72
|
0.89 Percentage
Standard Deviation 1.16
|
0.69 Percentage
Standard Deviation 0.50
|
0.50 Percentage
Standard Deviation 0.79
|
0.61 Percentage
Standard Deviation 0.56
|
0.37 Percentage
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: Day 1 to day 7Population: Full analysis set: included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
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
|
0.93 Percentage
Interval 0.2 to 2.2
|
0.42 Percentage
Interval 0.1 to 3.6
|
0.75 Percentage
Interval 0.0 to 1.4
|
0.20 Percentage
Interval 0.0 to 2.3
|
0.58 Percentage
Interval 0.0 to 1.4
|
0.29 Percentage
Interval 0.1 to 1.3
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Severe Hypoglycaemic Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day
|
1.01 Episodes
Standard Deviation 0.44
|
0.87 Episodes
Standard Deviation 0.49
|
1.06 Episodes
Standard Deviation 0.57
|
0.68 Episodes
Standard Deviation 0.43
|
0.86 Episodes
Standard Deviation 0.55
|
0.51 Episodes
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=7 Participants
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.
|
t65 Faster Aspart Cohort 3
n=8 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Severe hypoglycaemia
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Documented symptomatic hypoglycaemia
|
36 Episodes
|
38 Episodes
|
24 Episodes
|
42 Episodes
|
17 Episodes
|
25 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Asymptomatic hypoglycaemia
|
9 Episodes
|
15 Episodes
|
8 Episodes
|
6 Episodes
|
4 Episodes
|
9 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Probable symptomatic hypoglycaemia
|
4 Episodes
|
2 Episodes
|
3 Episodes
|
3 Episodes
|
1 Episodes
|
5 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Pseudo-hypoglycaemia
|
3 Episodes
|
8 Episodes
|
3 Episodes
|
6 Episodes
|
3 Episodes
|
6 Episodes
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=7 Participants
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.
|
t65 Faster Aspart Cohort 3
n=8 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe or BG confirmed symptomatic hypoglycaemia
|
13 Episodes
|
12 Episodes
|
4 Episodes
|
13 Episodes
|
6 Episodes
|
10 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe or BG confirmed hypoglycaemia
|
16 Episodes
|
15 Episodes
|
7 Episodes
|
14 Episodes
|
7 Episodes
|
12 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe hypoglycaemia
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Symptomatic BG confirmed hypoglycaemia
|
13 Episodes
|
12 Episodes
|
4 Episodes
|
13 Episodes
|
6 Episodes
|
10 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Asymptomatic BG confirmed hypoglycaemia
|
3 Episodes
|
3 Episodes
|
3 Episodes
|
1 Episodes
|
1 Episodes
|
2 Episodes
|
|
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
BG confirmed hypoglycaemia
|
16 Episodes
|
15 Episodes
|
7 Episodes
|
14 Episodes
|
7 Episodes
|
12 Episodes
|
SECONDARY outcome
Timeframe: Day 1 to day 7 (in both the treatment periods)Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=7 Participants
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.
|
t65 Faster Aspart Cohort 3
n=8 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Severe hypoglycaemia
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Documented symptomatic hypoglycaemia
|
30 Episodes
|
31 Episodes
|
21 Episodes
|
35 Episodes
|
14 Episodes
|
22 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Asymptomatic hypoglycaemia
|
5 Episodes
|
11 Episodes
|
5 Episodes
|
4 Episodes
|
4 Episodes
|
7 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Probable symptomatic hypoglycaemia
|
3 Episodes
|
2 Episodes
|
3 Episodes
|
2 Episodes
|
0 Episodes
|
4 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Pseudo-hypoglycaemia
|
2 Episodes
|
5 Episodes
|
3 Episodes
|
6 Episodes
|
2 Episodes
|
6 Episodes
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=7 Participants
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.
|
t65 Faster Aspart Cohort 3
n=8 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe hypoglycaemia
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Symptomatic BG confirmed hypoglycaemia
|
12 Episodes
|
9 Episodes
|
3 Episodes
|
9 Episodes
|
3 Episodes
|
9 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Asymptomatic BG confirmed hypoglycaemia
|
2 Episodes
|
1 Episodes
|
2 Episodes
|
0 Episodes
|
1 Episodes
|
2 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
BG confirmed hypoglycaemia
|
14 Episodes
|
10 Episodes
|
5 Episodes
|
9 Episodes
|
4 Episodes
|
11 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe or BG confirmed symptomatic hypoglycaemia
|
12 Episodes
|
9 Episodes
|
3 Episodes
|
9 Episodes
|
3 Episodes
|
9 Episodes
|
|
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe or BG confirmed hypoglycaemia
|
14 Episodes
|
10 Episodes
|
5 Episodes
|
9 Episodes
|
4 Episodes
|
11 Episodes
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=7 Participants
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.
|
t65 Faster Aspart Cohort 3
n=8 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Pseudo-hypoglycaemia
|
1 Episodes
|
3 Episodes
|
0 Episodes
|
0 Episodes
|
1 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Severe hypoglycaemia
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Documented symptomatic hypoglycaemia
|
6 Episodes
|
7 Episodes
|
3 Episodes
|
7 Episodes
|
3 Episodes
|
3 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Asymptomatic hypoglycaemia
|
4 Episodes
|
4 Episodes
|
3 Episodes
|
2 Episodes
|
0 Episodes
|
2 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Probable symptomatic hypoglycaemia
|
1 Episodes
|
0 Episodes
|
0 Episodes
|
1 Episodes
|
1 Episodes
|
1 Episodes
|
SECONDARY outcome
Timeframe: Day 1 to day 7 (in both the treatment periods)Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=7 Participants
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.
|
t65 Faster Aspart Cohort 3
n=8 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe hypoglycaemia
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Asymptomatic BG confirmed hypoglycaemia
|
1 Episodes
|
2 Episodes
|
1 Episodes
|
1 Episodes
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
BG confirmed hypoglycaemia
|
2 Episodes
|
5 Episodes
|
2 Episodes
|
5 Episodes
|
3 Episodes
|
1 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe or BG confirmed symptomatic hypoglycaemia
|
1 Episodes
|
3 Episodes
|
1 Episodes
|
4 Episodes
|
3 Episodes
|
1 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Severe or BG confirmed hypoglycaemia
|
2 Episodes
|
5 Episodes
|
2 Episodes
|
5 Episodes
|
3 Episodes
|
1 Episodes
|
|
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Symptomatic BG confirmed hypoglycaemia
|
1 Episodes
|
3 Episodes
|
1 Episodes
|
4 Episodes
|
3 Episodes
|
1 Episodes
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
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)
|
70.87 Percentage
Standard Deviation 9.35
|
66.79 Percentage
Standard Deviation 10.39
|
73.93 Percentage
Standard Deviation 6.14
|
70.44 Percentage
Standard Deviation 8.49
|
78.32 Percentage
Standard Deviation 6.96
|
73.82 Percentage
Standard Deviation 11.79
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.
Mean interstitial glucose level is calculated as the average of the available interstitial glucose values.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
Mean Interstitial-glucose Level
|
150.3 mg/dL
Standard Deviation 7.8
|
157.7 mg/dL
Standard Deviation 11.0
|
150.1 mg/dL
Standard Deviation 8.5
|
157.6 mg/dL
Standard Deviation 11.5
|
144.1 mg/dL
Standard Deviation 7.1
|
152.5 mg/dL
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events
|
2 Events
|
2 Events
|
2 Events
|
0 Events
|
0 Events
|
1 Events
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Safety analysis set (SAS): included all subjects receiving treatment. Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Emergent Infusion Site Reactions
|
0 Infusion site reaction
|
0 Infusion site reaction
|
0 Infusion site reaction
|
0 Infusion site reaction
|
0 Infusion site reaction
|
1 Infusion site reaction
|
SECONDARY outcome
Timeframe: Day 1 to day 7Population: Full analysis set: Included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.
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.
Outcome measures
| Measure |
t50 Faster Aspart Cohort 1
n=8 Participants
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.
|
t65 Faster Aspart Cohort 1
n=8 Participants
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.
|
t40 Faster Aspart Cohort 2
n=8 Participants
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.
|
t65 Faster Aspart Cohort 2
n=8 Participants
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.
|
t30 Faster Aspart Cohort 3
n=8 Participants
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.
|
t65 Faster Aspart Cohort 3
n=7 Participants
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.
|
|---|---|---|---|---|---|---|
|
Total Insulin Dose Per Day
|
0.60 U/Kg/day
Standard Deviation 0.12
|
0.63 U/Kg/day
Standard Deviation 0.12
|
0.65 U/Kg/day
Standard Deviation 0.13
|
0.67 U/Kg/day
Standard Deviation 0.16
|
0.63 U/Kg/day
Standard Deviation 0.12
|
0.64 U/Kg/day
Standard Deviation 0.18
|
Adverse Events
t50 Faster Aspart Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
t65 Faster Aspart Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
t40 Faster Aspart Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
t65 Faster Aspart Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
t30 Faster Aspart Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
t65 Faster Aspart Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
t50 Faster Aspart Cohort 1
n=8 participants at risk
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.
|
t65 Faster Aspart Cohort 1
n=8 participants at risk
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.
|
t40 Faster Aspart Cohort 2
n=8 participants at risk
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.
|
t65 Faster Aspart Cohort 2
n=8 participants at risk
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.
|
t30 Faster Aspart Cohort 3
n=8 participants at risk
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.
|
t65 Faster Aspart Cohort 3
n=7 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • Number of events 1 • 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.
|
12.5%
1/8 • Number of events 2 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/7 • 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.
|
|
General disorders
Infusion site reaction
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/7 • 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.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/7 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/7 • 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.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER