A Phase 1 interventional study of NNC0363-0845 and Placebo (NNC0363-0845) in Healthy Volunteers and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D.
The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours.
For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks.
Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 68 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.
Part 1 (healthy subjects):
Part 2 and 3 (subjects with type 1 diabetes mellitus):
Exclusion Criteria:
Part 1 (healthy subjects) Part 2 and Part 3 (subjects with type 1 diabetes mellitus):
Healthy volunteers will receive either NNC0363-0845 or placebo
Drug: NNC0363-0845 · Drug: Placebo (NNC0363-0845)
Participants with T1D will receive either NNC0363-0845 or insulin degludec
Drug: NNC0363-0845 · Drug: Insulin degludec
Participants with T1D will receive NNC0363-0845
Drug: NNC0363-0845
A single dose administered s.c. (subcutaneously, under the skin)
A single dose administered s.c.
A single dose administered s.c.
Number of treatment-emergent adverse events (AEs)
Number of events
Time frame: Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of treatment-emergent adverse events (AEs)
Number of events
Time frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Time frame: Part 1 and 2 From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Time frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
pmol\*h/L
Time frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
pmol\*h/L
Time frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
pmol/L
Time frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
pmol/L
Time frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S