Diabetes Mellitus, Type 1Phase 2NCT03816761

Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes

A Phase 2 study testing Fast-acting insulin aspart and iLet™ in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Fast-acting insulin aspart and iLet™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 25 Feb 2019to 10 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, age more than or equal to 18 years and less than or equal to 75 years at the time of signing informed consent
Diagnosed with type 1 diabetes mellitus more than or equal to 1 year prior to the day of screening
Treated with continuous subcutaneous insulin infusion more than or equal to 1 year prior to the day of screening
Have a mean total daily dose of insulin more than or equal to 20 units
Familiar with continuous glucose monitoring as judged by the investigator

Show all 11Show fewer

Has someone over 18 years of age who (i) lives with them, (ii) has access to where they sleep, (iii) is willing to be in the house when the subject is sleeping, and (iv) is willing to receive calls from the study staff and check the welfare of the study subject
Body mass index (BMI) less than or equal to 35.0 kg/m^2 at screening
Glycated haemoglobin (HbA1c) more than or equal to 6.5% (47 mmol/mol) and less than or equal to 9% (75 mmol/mol) at screening
Able and willing to remain in a designated place for the specified duration of the 'in-patient' periods
Lives within a 120-minute drive away from the central monitoring location (site)

Who cannot join

Known or suspected hypersensitivity to trial product(s) or related products
Previous participation in this trial. Participation is defined as signed informed consent
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening
Any disorder, except for conditions associated with diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism during the trial

Show all 16Show fewer

Impaired liver function, defined as Alanine Aminotransferase (ALT) more than or equal to 2.5 times or Bilirubin more than 1.5 times upper normal limit at screening
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 60 ml/min/1.73 m^2
Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening
Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question 8
Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 180 days prior to the day of screening
Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Inadequately treated blood pressure defined as Grade 3 hypertension or higher (systolic more than or equal to 180 mmHg or diastolic more than or equal to 110 mmHg) at screening
Unwilling or unable to avoid acetaminophen throughout the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

Novo Nordisk Investigational Site
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: An Exploratory Trial Investigating the Safety and Efficacy of Fast-acting Insulin Aspart in a Closed-loop Insulin Delivery System (Bionic Pancreas) in Adults With Type 1 Diabetes

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.

Conditions: Diabetes Mellitus, Type 1
Being tested: Fast-acting insulin aspart, iLet™
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fast-acting insulin aspartDrug
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.
iLet™Device
The bionic pancreas including pigtail adapters, used in insulin-only configuration

Study groups in NCT03816761
Study group	Role	What they receive
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. Receives: Drug: Fast-acting insulin aspart; Device: iLet™
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. Receives: Drug: Fast-acting insulin aspart; Device: iLet™

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 1 to day 7

Secondary outcomes (13)

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.
Measured: 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.
Measured: 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:
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).
Measured: 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:
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.
Measured: 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:
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).
Measured: 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:
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.
Measured: 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:
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).
Measured: 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:
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.
Measured: 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.
Measured: Day 1 to day 7
Mean Interstitial-glucose Level
Mean interstitial glucose level is calculated as the average of the available interstitial glucose values.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 201910 Jun 2019

First posted25 Jan 2019
Study start25 Feb 2019
Primary completion31 May 2019
Study completion10 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03816761
Sponsor's protocol ID: NN1218-4360
Other IDs: U1111-1205-1788
Status last verified: May 2020
First submitted: 23 Jan 2019
Last updated: 11 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

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.
PubMed 34146238

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Trial Investigating the Safety and Efficacy of Fast-acting Insulin Aspart in a Closed-loop Insulin Delivery System (Bionic Pancreas) in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT03816761
Acronym / sponsor ID: NN1218-4360
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 25 Feb 2019 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 10 Jun 2019 (actual)
First posted: 25 Jan 2019 (actual)
Results: Posted 11 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Fast-acting insulin aspart, default tmax setting	Experimental	Drug: Fast-acting insulin aspart, Device: iLet™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	Drug: Fast-acting insulin aspart, Device: iLet™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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, age more than or equal to 18 years and less than or equal to 75 years at the time of signing informed consent
Diagnosed with type 1 diabetes mellitus more than or equal to 1 year prior to the day of screening
Treated with continuous subcutaneous insulin infusion more than or equal to 1 year prior to the day of screening
Have a mean total daily dose of insulin more than or equal to 20 units

Key exclusion criteria (16 listed)

Known or suspected hypersensitivity to trial product(s) or related products
Previous participation in this trial. Participation is defined as signed informed consent
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening
Any disorder, except for conditions associated with diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fast-acting insulin aspartIn 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.	Drug	Fast-acting insulin aspart, default tmax setting, Fast-acting insulin aspart, non-default tmax setting
iLet™The bionic pancreas including pigtail adapters, used in insulin-only configuration	Device	Fast-acting insulin aspart, default tmax setting, Fast-acting insulin aspart, non-default tmax setting

Primary outcome

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)
Time frame: Day 1 to day 7
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.
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
Time frame: Day 1 to day 7
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.

13 secondary outcomes

Number of Treatment Emergent Severe Hypoglycaemic Episodes
Time frame: Day 1 to day 7
Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day
Time frame: Day 1 to day 7
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Time frame: Day 1 to day 7
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Time frame: Day 1 to day 7
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Time frame: Day 1 to day 7 (in both the treatment periods)
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Time frame: Day 1 to day 7
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
Time frame: Day 1 to day 7
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Time frame: 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 frame: Day 1 to day 7
Mean Interstitial-glucose Level
Time frame: Day 1 to day 7
Number of Treatment Emergent Adverse Events
Time frame: Day 1 to day 7
Number of Treatment Emergent Infusion Site Reactions
Time frame: Day 1 to day 7
Total Insulin Dose Per Day
Time frame: Day 1 to day 7

Results and safety

Results posted to the registry on 11 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: t65 First, Then t50	4	4
Cohort 1: t50 First, Then t65	4	4
Cohort 2: t65 First, Then t40	4	4
Cohort 2: t40 First, Then t65	4	4
Cohort 3: t65 First, Then t30	4	4
Cohort 3: t30 First, Then t65	4	3

Primary outcome: 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)

Time frame: Day 1 to day 7. Mean (Standard Deviation). Unit: Percentage

Measure	t50 Faster Aspart Cohort 1 n = 8	t65 Faster Aspart Cohort 1 n = 8	t40 Faster Aspart Cohort 2 n = 8	t65 Faster Aspart Cohort 2 n = 8	t30 Faster Aspart Cohort 3 n = 8	t65 Faster Aspart Cohort 3 n = 7
Value	0.98 (0.72)	0.89 (1.16)	0.69 (0.50)	0.50 (0.79)	0.61 (0.56)	0.37 (0.41)

Population analysed: Full analysis set: included all randomised subjects receiving treatment.Number of participants analysed=participants with available data.

Primary outcome: 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

Time frame: Day 1 to day 7. Median (Full Range). Unit: Percentage

Measure	t50 Faster Aspart Cohort 1 n = 8	t65 Faster Aspart Cohort 1 n = 8	t40 Faster Aspart Cohort 2 n = 8	t65 Faster Aspart Cohort 2 n = 8	t30 Faster Aspart Cohort 3 n = 8	t65 Faster Aspart Cohort 3 n = 7
Value	0.93 (0.2 to 2.2)	0.42 (0.1 to 3.6)	0.75 (0.0 to 1.4)	0.20 (0.0 to 2.3)	0.58 (0.0 to 1.4)	0.29 (0.1 to 1.3)

Population analysed: Full analysis set: included all randomised subjects receiving treatment. Number of participants analysed=participants with available data.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
t50 Faster Aspart Cohort 1	0 of 8 (0%)	2 of 8 (25%)	0 of 8
t65 Faster Aspart Cohort 1	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
t40 Faster Aspart Cohort 2	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
t65 Faster Aspart Cohort 2	0 of 8 (0%)	0 of 8 (0%)	0 of 8
t30 Faster Aspart Cohort 3	0 of 8 (0%)	0 of 8 (0%)	0 of 8
t65 Faster Aspart Cohort 3	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34146238Russell 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.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Diabetes Mellitus, Type 1

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Reporting Anchor and Disclosure (1452) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fast-acting insulin aspart and iLet™ in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Day 1 to day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03816761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.