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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Participants will receive subcutaneous NNC0194-0499 once weekly.
Participants will receive placebo matched to NNC0194-0499 subcutaneously.
Participants will receive subcutaneous semaglutide once weekly.
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
Percentage point (%-points).
Time frame: From baseline (day -14 - -1) to day 36-49 / day 106-119
Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
%-points.
Time frame: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in coefficient of variation (CV) of sensor glucose, total
%-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
Change in mean sensor glucose (SG)
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
Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)
%-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
Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL)
%-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
Time below range (TBR) <3.9 mmol/L (70 mg/dL)
% of time.
Time frame: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
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Time below range (TBR)<3.0 mmol/L (54 mg/dL)
% of time.
Time frame: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL)
%-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
Change in mean total daily insulin dose per kg
Ratio to baseline.
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
Change in triglycerides
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
Number of adverse events (AEs)
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 severe hypoglycaemic episodes (level 3)
Number of episodes.
Time frame: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211