A Phase 1 interventional study of NNC0471-0119 and Fast-acting insulin aspart in Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Austria. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-01-03.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This study is looking at the safety of the new medicine, insulin NNC0471-0119, its concentrations in the blood and effect on blood sugar for the treatment of type 1 diabetes. Insulin NNC0471-0119 will be compared to faster aspart. The purpose of this study is to test how insulin NNC0471-0119 is tolerated by participants body, how it is transported in participants bloodstream, how long it stays there and how the blood sugar is lowered compared to faster aspart. Participants will get either the new insulin NNC0471-0119 or faster aspart-which treatment participants get is decided by chance. It is the first time insulin NNC0471-0119 is tested in people. Faster aspart is a globally used medication for treatment of diabetes mellitus. Participants will get one single injection in a fasting state which will take place at the study site. The medicine will be injected under the skin in the stomach. The study will last for about 13-53 days, depending on individual visit schedule. Participants will have four clinic visits with the study doctor, one of which will require an in-house visit period of 3 days. During the in-house visit, two intravenous cannulas will be inserted for sampling of blood and infusion of insulin. Participants cannot be in the study if the study doctor thinks that there are risks to their health. Women: Women cannot take part if they are of childbearing potential.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 48 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomised to NNC0471-0119
Drug: NNC0471-0119
Participants randomised to faster aspart.
Drug: Fast-acting insulin aspart
Participants will be randomised to either of five dose levels 0.3, 0.6, 1.2, 2.4 or 3.6 of NNC0471-0119 nanomol per kilogram body weight, which will be administered as a single dose. NNC0471-0119 will be administered subcutaneously (s.c., under the skin) in fasting state.
Participants will get a fixed dose of 0.2 units of fast-acting insulin aspart (Fiasp®) per kilogram body weight, administered subcutaneously (s.c., under the skin) in fasting state.
Number of adverse events (AEs)
Number of events
Time frame: From investigational medicinal product (IMP) administration at day 1 (Visit 2) and up to 22 days post IMP administration (Visit 3)
Number of hypoglycaemic episodes
Number of episodes
Time frame: 0 to 24 hours after IMP administration
AUCNNC0471-0119,0-30 min/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 0-30 min and 0-t, where t is the last observed time point with insulin concentration above lower limit of quantification (LLOQ).
% (Percent)
Time frame: 0 to 12 hours after IMP administration
AUCNNC0471-0119,2h-t/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 2 hours to t and 0 to t, where t is the last observed time point with insulin concentration above LLOQ.
Time frame: 0 to 12 hours after IMP administration
AUCNNC0471-0119, 0-t: Area under the serum NNC0471-0119 concentration-time curve from 0 to t, where t is the last observed time point with insulin concentration above LLOQ.
h\*pmol/L
Time frame: 0 to 12 hours after IMP administration
Cmax,NNC0471-0119: Maximum observed serum NNC0471- 0119 concentration
pmol/L
Time frame: 0 to 12 hours after IMP administration
tmax,NNC0471-0119: Time to maximum observed serum NNC0471-0119 concentration
Minutes
Time frame: 0 to 12 hours after IMP administration
t½, NNC0471-0119: Terminal half-life for NNC0471-0119
Minutes
Time frame: 0 to 12 hours after IMP administration
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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