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
Not Applicable
Recruiting
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT07087795
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A: NNC0194-0499/Placebo NNC0194-0499 After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo. Part A: NNC0194-0499/Placebo Placebo After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo. Part B: NNC0194-0499/Placebo + Semaglutide Semaglutide After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide. Part B: NNC0194-0499/Placebo + Semaglutide NNC0194-0499 After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide. Part B: NNC0194-0499/Placebo + Semaglutide Placebo After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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).
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 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.
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.
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.
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.
Trial Locations
- Locations (1)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany
Profil Institut für Stoffwechselforschung GmbH🇩🇪Neuss, Germany