A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar… (NCT07087795) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes
Germany96 participantsStarted 2025-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* Male or female.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index 22-35 kilogram per square meter (kg/m\^2) (both inclusive) for Part A and 27-35(kg/m\^2) (both inclusive) for Part B at the day of screening.
* Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening.
* Treated with multiple daily insulin injections and stable insulin dose greater than (\>) 90 days prior to the day of screening, as judged by the investigator.
* Use of Continuous glucose monitoring (CGM) device \> 180 consecutive days prior to the day of screening.
* Glycated haemoglobin (HbA1c) from 7.2 - 9.0% (both inclusive).
* Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Ability and willingness to wear the Novo Nordisk provided CGM device according to the protocol including replacement of CGM sensor at home.
* Ability and willingness to refrain from wearing own CGM/Flash glucose monitor for the duration of the study, as judged by the investigator.
Exclusion Criteria:
* Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion …
What they're measuring
1
Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
Timeframe: From baseline (day -14 - -1) to day 36-49 / day 106-119
2
Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
Timeframe: From baseline (day -14 - -1) to day 92-105 / day 162-175