Diabetes Mellitus, Type 1
Conditions
Brief 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.
Interventions
DRUGNNC0194-0499
Participants will receive subcutaneous NNC0194-0499 once weekly.
DRUGPlacebo
Participants will receive placebo matched to NNC0194-0499 subcutaneously.
DRUGSemaglutide
Participants will receive subcutaneous semaglutide once weekly.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in coefficient of variation (CV) of sensor glucose, total | 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. |
| Change in mean sensor glucose (SG) | 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). |
| Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL) | 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. |
| Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL) | 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 below range (TBR) <3.9 mmol/L (70 mg/dL) | Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175 | % of time. |
| Time below range (TBR)<3.0 mmol/L (54 mg/dL) | Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175 | % of time. |
| Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) | 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. |
| Change in mean total daily insulin dose per kg | 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. |
| Change in triglycerides | 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. |
| Number of adverse events (AEs) | Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211 | Number of events. |
| Number of severe hypoglycaemic episodes (level 3) | Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211 | Number of episodes. |
Countries
Germany
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed