A Phase 1 interventional study of insulin degludec/insulin aspart and insulin degludec/insulin aspart in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.
The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.
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
Drug: insulin degludec/insulin aspart
Drug: insulin degludec/insulin aspart
Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 30
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Area (AUC) under the glucose infusion rate curve
Time frame: From 0 to 24 hours after single-dose administration
Area (AUC) under the insulin aspart concentration time curve
Time frame: From 0 to 24 hours after single-dose administration
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S