Diabetes Mellitus, Type 1
Conditions
Brief summary
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
Interventions
DRUGInsulin icodec
Insulin icodec will be administered as subcutaneous injection
DRUGInsulin glargine
Insulin glargine will be administered as subcutaneous injection.
DRUGInsulin aspart
Insulin aspart will be administered as a subcutaneous injection.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening. * Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening. * HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis. * Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Previous participation in this study. Participation is defined as signed informed consent. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening. * Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids). * Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycosylated haemoglobin (HbA1c) | From baseline (week 0) to week 26 | Measured in percentage (%)-points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) | From baseline (week-2-0) to week 22-26 | Measured in %-points. |
| Time spent less than (<)3.0 mmol/L (54 mg/dL) | From week 22 to week 26 | Measured in % of time. |
| Change in time spent greater than (>)10.0 mmol/L (180 mg/dL) | From baseline (week-2-0) to week 22-26 | Measured in %-points. |
| Number of severe hypoglycaemic episodes (level 3) | From baseline (week 0) to week 31 | Measured as number of episodes. |
| Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter) | From baseline (week 0) to week 31 | Measured as number of episodes. |
| Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3) | From baseline (week 0) to week 31 | Measured as number of episodes. |
| Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]) | From baseline (week 0) to week 31 | Measured as number of episodes. |
| Mean total weekly insulin dose | From week 24 to week 26 | Measured in insulin units. |
| Change in body weight | From baseline (week 0) to week 26 | Measured in Kilogram (kg). |
Countries
Australia, Canada, Germany, Poland, Puerto Rico, Romania, Slovakia, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed