Diabetes Mellitus, Type 1 MedDRA version: 21.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female aged 18 years or more at the time of signing informed consent. - Diagnosed with type 1 diabetes mellitus at least 1 year prior to the day of screening. - Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) at least 1 year prior to the day of screening. - HbA1c below 10% at screening visit based on analysis from central laboratory. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 522 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: - Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. - Chronic heart failure classified as New York Heart Association (NYHA) Class IV at screening. - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, in subjects with T1D. This includes comparing the difference in change from baseline in HbA1c between once weekly insulin icodec and once daily insulin degludec both in combination with insulin aspart after 26 weeks of treatment to a non-inferiority limit of 0.3%.;Secondary Objective: To compare the safety and patient reported outcomes of once weekly insulin icodec versus once daily insulin degludec, both in combination with insulin aspart, in subjects with T1D.;Primary end point(s): 1. Change in HbA1c;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in fasting plasma glucose (FPG) 2. Time in range 3.9-10.0 mmol/L (70-180 mg/dL) *using continuous glucose monitoring (CGM) system, Dexcom G6 3. Change in DTSQs (DiabetesTreatment Satisfaction Questionnaire) in total treatment satisfaction 4. Change in HbA1c 5. Number of severe hypoglycaemic episodes (level 3) 6. Number of clinically significant hypoglycaemic episodes (level 2) ( 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 15. Mean total weekly insulin dose 16. Mean total weekly insulin dose 17. Change in body weight;Timepoint(s) of evaluation of this end point: 1., 3., 5.-7., 11. and 17. From baseline (week 0) to week 26 2. From week 22 to week 26 4. From baseline (week 0) to week 52 8.-10. and 12. From baseline (week 0) to week 57 13.-14. From week 22 to week 26 15. From week 24 to week 26 16. From week 50 to week 52 | — |
Countries
Canada, European Union, Germany, India, Italy, Japan, Netherlands, Russian Federation, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Transparency (1452)
Novo Nordisk A/S
Outcome results
None listed