Clinical trial NCT05262595: A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump
Official title: A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of Three Formulations of NNC0471-0119 When Administered as One Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.

The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.

The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).

Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.

Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.

The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.

During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.

Women: Women cannot take part if they are of childbearing potential.


Eligibility criteria: Inclusion Criteria:

* Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with T1DM for more than1 year prior to the day of screening.
* Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
* Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.

Exclusion Criteria:

* Known or suspected hypersensitivity to study interventions or related products.
* Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.

Primary outcomes:
measure: AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
timeFrame: 0 to 12 hours after bolus infusion
Secondary outcomes:
measure: AUC (NNC0471-0119,0-t,basal-corrected)
timeFrame: 0 to 12 hours after bolus infusion
measure: AUC (NNC0471-0119,0-30min,basal-corrected)
timeFrame: 0 to 30 minutes after bolus infusion
measure: AUC (NNC0471-0119,2h-t,basal-corrected)
timeFrame: 2 to 12 hours after bolus infusion
measure: AUC (NNC0471-0119,2h-t,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
timeFrame: 0 to 12 hours after bolus infusion
measure: Cmax,NNC0471-0119,basal-corrected: Maximum observed basal-corrected serum NNC0471-0119 concentration
timeFrame: 0 to 12 hours after bolus infusion
measure: Number of adverse events (AEs)
timeFrame: From start of first investigational medicinal product ( IMP) basal rate infusion (Visit 2, day -1) until completion of post-treatment end-of-study visit (Visit 6)
measure: AUC (GIR,0-t,basal-corrected)
timeFrame: 0 to 12 hours after bolus infusion
measure: AUC (GIR,0-1h,basal-corrected)
timeFrame: 0 to 1 hour after bolus infusion
measure: AUC (GIR,0-1h,basal-corrected/AUC (GIR,0-t,basal-corrected)
timeFrame: 0 to 12 hours after bolus infusion
measure: GIRmax,basal-corrected: Maximum observed basal-corrected GIR
timeFrame: 0 to 12 hours after bolus infusion
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: