A Phase 1 interventional study of Insulin Icodec in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Austria. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.
Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.
Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.
The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.
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 46 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 will receive individualised weekly doses of insulin icodec
Drug: Insulin Icodec
Participants will receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment.
AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state
pmol\*h/L
Time frame: From 0 to 168 hours after trial product administration (Day 50)
AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state
mg/kg
Time frame: From 0 to 36 hours after trial product administration (Day 36)
AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state
mg/kg
Time frame: From 40 to 64 hours after trial product administration (Day 43)
AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state
mg/kg
Time frame: From 144 to 168 hours after trial product administration (Day 50)
AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state
mg/kg
Time frame: From 0 to 168 hours after trial product administration (Day 50)
AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state
pmol\*h/L
Time frame: From 0 to 168 hours after trial product administration (Day 36 and 43)
Dose-normalised AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose
(pmol\*h/L)/(U/kg)
Time frame: From 0 to 168 hours after trial product administration (Day 50)
Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state
pmol/L
Time frame: From 0 to 168 hours after trial product administration (Day 36, 43 and 50)
Dose-normalised Cmax,Ico,SS, Maximum observed serum insulin icodec concentration after the last dose divided by dose
(pmol/L)/(U/kg)
Time frame: From 0 to 168 hours after trial product administration (Day 50)
tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose
hours
Time frame: From 0 to 168 hours after trial product administration (Day 50)
t½,Ico,SS, Terminal half-life for insulin icodec at steady state
hours
Time frame: Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S