Clinical trial

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

Active, not recruiting · Phase 1 · 1 countries · Registry ID NCT07087795

Active, not recruitingPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 1

Full registry criteria

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 might jeopardise participant's safety or compliance with the protocol. * Treatment with glucagon-like peptide-1(GLP-1) RA within 90 days before screening. * Use of any medication with unknown or unspecified content within 90 days before screening. * Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity). * Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days prior to the day of screening. * Any episode of diabetic ketoacidosis within 90 days before screening.

Treatments and study arms

NNC0194-0499

Drug

Participants will receive subcutaneous NNC0194-0499 once weekly.

Placebo

Drug

Participants will receive placebo matched to NNC0194-0499 subcutaneously.

Semaglutide

Drug

Participants will receive subcutaneous semaglutide once weekly.

Primary outcomes

Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)From baseline (day -14 - -1) to day 36-49 / day 106-119

Percentage point (%-points).

Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)From baseline (day -14 - -1) to day 92-105 / day 162-175

%-points.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Profil Institut für Stoffwechselforschung GmbH🇩🇪 Neuss, Germany