Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
NCT Number: NCT06685185
This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Neuss, 41460, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part 1A SAD (healthy participants)
Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
Exclusion criteria
Part 1A SAD (healthy participants)
Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
NNC0363-1063 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Insulin degludec will be administered subcutaneously.
Other names: Tresiba
Insulin detemir will be administered subcutaneously.
Other names: Levemir
Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Measured in number of events.
Time frame: From IMP administration at day 1 up to 7 days
Measured in millilitre per hour*kilogram (mL/[h*kg]).
Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test
Measured in hours*millimoles per litre (h*mmol/L).
Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Measured in number of episodes.
Time frame: Up to 7 days
Measured in hours*picomoles per litre (h*pmol/L).
Time frame: Up to 2 days
Measured in h*pmol/L.
Time frame: Up to 7 days
Measured in picomoles per litre (pmol/L).
Time frame: Up to 7 days
Measured in h*pmol/L.
Time frame: Up to 2 days
Measured in h*pmol/L.
Time frame: Up to 7 days
Measured in pmol/L.
Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
Measured in h*mmol/L.
Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Measured in h*mmol/L.
Time frame: From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Measured in h*mmol/L.
Time frame: From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Measured in h*mmol/L.
Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test
Measured in millimoles per litre (mmol/L).
Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test
Measured in hours.
Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)
Measured in mmol/L.
Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)
Measured in mmol/L.
Time frame: At day 2 of visit 2 and visit 3 after last IMP administration
Measured in h*pmol/L.
Time frame: At day 2 of visit 2 and visit 3 after last IMP administration
Measured in pmol/L.
Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)
Measured in number of events.
Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)
Measured in number of episodes.
Novo Nordisk A/S
Industry
A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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