Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
NCT Number: NCT07087795
This study is testing the effect of a new study medicine NNC0194-0499 in type 1 diabetes. The purpose of the study is to compare the effect of NNC0194-0499 on the blood sugar levels of participants with type 1 diabetes when taken in combination with semaglutide or placebo. All participants will receive standard of care insulin treatment. The study will last for about 36 weeks.
This study is active but is not currently recruiting participants.
Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Neuss, 41460, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive subcutaneous NNC0194-0499 once weekly.
Participants will receive placebo matched to NNC0194-0499 subcutaneously.
Participants will receive subcutaneous semaglutide once weekly.
Time frame: From baseline (day -14 - -1) to day 36-49 / day 106-119
Percentage point (%-points).
Time frame: From baseline (day -14 - -1) to day 92-105 / day 162-175
%-points.
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
%-points.
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Millimoles per liter (mmol/L).
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
%-points.
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
%-points.
Time frame: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
% of time.
Time frame: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
% of time.
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
%-points.
Time frame: Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175
Ratio to baseline.
Time frame: Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176
Ratio to baseline.
Time frame: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211
Number of events.
Time frame: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211
Number of episodes.
Novo Nordisk A/S
Industry
A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People 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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