Phase 2 N=24 Randomized Double-blind Treatment

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

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT03816761 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) — 0.98; 0.89; 0.69; 0.50 Percentage

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fast-acting insulin aspart (Drug); iLet™ (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novo Nordisk A/S
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage)	0.98; 0.89; 0.69; 0.50; 0.61; 0.37	—
PRIMARY Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median	0.93; 0.42; 0.75; 0.20; 0.58; 0.29	—
SECONDARY Number of Treatment Emergent Severe Hypoglycaemic Episodes	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day	1.01; 0.87; 1.06; 0.68; 0.86; 0.51	—
SECONDARY Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification	0; 0; 0; 0; 0; 0	—
SECONDARY Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages)	70.87; 66.79; 73.93; 70.44; 78.32; 73.82	—
SECONDARY Mean Interstitial-glucose Level	150.3; 157.7; 150.1; 157.6; 144.1; 152.5	—
SECONDARY Number of Treatment Emergent Adverse Events	2; 2; 2; 0; 0; 1	—
SECONDARY Number of Treatment Emergent Infusion Site Reactions	0; 0; 0; 0; 0; 1	—
SECONDARY Total Insulin Dose Per Day	0.60; 0.63; 0.65; 0.67; 0.63; 0.64	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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
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)

Exclusion Criteria

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03816761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.