A Phase 1 interventional study of Insulin icodec and placebo in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-08-27.
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 safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 50 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.
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Exclusion Criteria:
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
Drug: Insulin icodec · Drug: placebo
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
Drug: insulin degludec · Drug: placebo
Administered once weekly subcutaneously (s.c., under the skin) for 35 days
Also known as: insulin 287
Administered once daily subcutaneously for 35 days
Administered once daily subcutaneously for 35 days
Administered once weekly subcutaneously for 35 days
Number of treatment emergent adverse events (TEAE)
Time frame: From the first trial product administration at day 1 until completion of the post-treatment follow-up visit (day 68 - 79)
AUCI287,τ,SS, area under the steady-state serum insulin 287 concentration-time curve
Time frame: During one dosing interval at steady-state from 0 to 168 hours after last dose (day 29)
AUCGIR,0-24h,SS, area under the glucose infusion rate-time curve at steady state
Time frame: At day 30 and day 35
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S