type 2 diabetes
Conditions
Interventions
-Two arm for insulin icodec and insulin glargine
-The study will consist of 3 periods: a Screening Period, a Treatment Period, and a Follow-Up Period.
-Implementation of blood sampling tests, etc. spe
Sponsors
Nishida Hiroko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged above or equal to 18 years at the time of signing informed consent. 2. Diagnosed with T2D>= 180 days prior to the day of screening. 3. HbA1c from 7.0-10.0% (53.0 85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. 4. 4.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, 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-receptor agonists 5. Body mass index (BMI) <= 40.0 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Any episodesa of diabetic ketoacidosis within 90 days prior to the day of screening. 2. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. 3. Chronic heart failure classified as being in New York Heart Association Class IV at screening. 4. 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). 5. 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 |
|---|---|
| The objective of this trial is to demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus regimen. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%. | — |
Countries
Belgium, India, Italy, Japan, Mexico, Netherlands, Rumania, Russia, United States
Contacts
Public ContactHiroko Nishida
Novo Nordisk Pharma Ltd.
Outcome results
None listed