A Phase 1 interventional study of NNC 0148-0000-0362 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 2015-05-29.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers.
The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.
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This study's enrollment of 83 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Drug: NNC 0148-0000-0362 · Drug: insulin glargine · Drug: placebo
Drug: NNC 0148-0000-0362
Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
Subjects will receive a single dose of oral placebo within each dose group
Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period
Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period
Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period
Number of adverse events
Time frame: Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit
Area under the serum insulin concentration-time curve (with Trial part 1)
Time frame: From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively
Area under the glucose infusion rate (GIR)-time curve (Trial part 1)
Time frame: From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively
Area under the serum insulin concentration-time curve (Trial part 2)
Time frame: From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S