A Phase 1 interventional study of Insulin icodec in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.
Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.
The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.
Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 25 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:
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
Drug: Insulin icodec
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
Drug: Insulin icodec
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
Drug: Insulin icodec
A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.
AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
From 0 hours until infinity after trial product administration (pmol\*h/L)
Time frame: Day 1
Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose
From 0 hours until infinity after trial product administration (pmol/L)
Time frame: Day 1
tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose
From 0 hours until infinity after trial product administration (hours)
Time frame: Day 1
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S