diabetes Diabetes Mellitus type 2
Conditions
Interventions
Subjects will be randomised (1:1) to receive once weekly insulin icodec or once
daily insulin glargine, both in combination with 2-4 times daily injections of
insulin aspart. Insulin icodec, insulin
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female aged above or equal to 18 years at the time of signing informed consent. - Diagnosed with T2D * 180 days prior to the day of screening. - HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. - Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, faster acting insulin lispro, insulin glulisine) * 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses * 90 days prior to screening: * Metformin * Sulfonylureas * Meglitinides (glinides) * DPP-4 inhibitors * SGLT2 inhibitors * Thiazolidinediones * Alpha-glucosidase inhibitors * Oral combination products (for the allowed individual oral anti-diabetic drugs) * Oral or injectable GLP-1 RAs - Body mass index (BMI) * 40.0 kg/m2
Exclusion criteria
Exclusion criteria: - Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening. - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. - Chronic heart failure classified as being in New York Heart Association 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 |
|---|---|
| Change in HbA1c (%) from baseline week 0 (V2) to week 26 (V28) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints * Change in fasting plasma glucose from baseline week 0 (V2) to week 26 (V28) * Time in target-range 3.9*10.0 mmol/L (70-180 mg/dL) from week 22 (V24) to week 26 (V28) Secondary safety endpoints * Number of severe hypoglycaemic episodes (level 3) from baseline week 0 (V2) to week 31 (V30) * Number of clinically significant hypoglycaemic episodes (level 2) ( 10 mmol/L (180 mg/dL) from week 22 (V24) to week 26 (V28) * Mean weekly insulin dose from week 24 (V26) to week 26 (V28) * Change in body weight from baseline week 0 (V2) to week 26 (V28) | — |
Countries
Netherlands
Outcome results
None listed