A Phase 1 interventional study of Insulin 320 and insulin glargine in Diabetes, Diabetes Mellitus, Type 2 and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-01.
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 320 in healthy subjects.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 84 is close to 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:
Drug: Insulin 320 · Drug: insulin glargine · Drug: placebo
Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.
As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
Number of treatment-emergent adverse events
Time frame: From the time of trial product administration and until 12 days after trial product administration
Area under the serum insulin concentration-time curve
Time frame: From 0 to 288 hours after a single dose (SD)
Area under the glucose infusion rate-time curve
Time frame: From 0 to 24 hours after a single dose
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S