A Phase 1 interventional study of insulin degludec/insulin aspart 15 and insulin degludec/insulin aspart in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Austria. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-03-05.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 33 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:
Drug: insulin degludec/insulin aspart 15 · Drug: placebo
Drug: insulin degludec/insulin aspart · Drug: placebo
Drug: insulin degludec
Drug: insulin aspart
Drug: insulin degludec · Drug: insulin aspart
Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).
Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).
Also known as: IDegAsp
Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).
Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).
Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
Area under the glucose infusion rate curve
Time frame: From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp)
Area under the serum IDeg concentration-time curve
Time frame: From 0 to 120 hours after single dose
Area under the serum IAsp concentration-time curve
Time frame: From 0 to 12 hours after single dose
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S