A Phase 1 interventional study of Insulin icodec in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing.
The study will last for about 8 weeks. Participants will have 8 visits with the study doctor in the clinical research unit.
Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 mL (about a spoonful).
Participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ).
Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 25 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novo Nordisk A/S is the lead sponsor of 1,401 studies on the registry; 102 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.
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Exclusion Criteria:
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Drug: Insulin icodec
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Drug: Insulin icodec
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Drug: Insulin icodec
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
Drug: Insulin icodec
Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks.
AUC,Ico,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 last measurement time 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 last measurement time after trial product administration (hours)
Time frame: Day 1
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin icodec