A Phase 1 interventional study of insulin 287 and insulin glargine in Diabetes and Diabetes Mellitus, Type 2, 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 2017-03-01.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 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.
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Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
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Exclusion Criteria:
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287 · Drug: insulin glargine · Drug: placebo
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287 · Drug: insulin glargine · Drug: placebo
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287 · Drug: insulin glargine · Drug: placebo
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287 · Drug: insulin glargine · Drug: placebo
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287 · Drug: insulin glargine · Drug: placebo
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287 · Drug: insulin glargine · Drug: placebo
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287 · Drug: insulin glargine · Drug: placebo
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Oral placebo adminstered corresponding to insulin 287 treatment
Number of adverse events (AEs)
Time frame: As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)
Area under the serum insulin concentration-time curve
Time frame: From 0 to 648 hours after a single dose
Area under the glucose infusion rate (GIR)-time curve
Time frame: From 0 to 24 hours after a single dose
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S