A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 1)
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 1)clinicaltrials.gov
- Male or female aged above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2D) 180 days or more prior to the day of screening.
- HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- Stable daily dose(s) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s):
- Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose.
- Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose.
- Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose):
- Meglitinides (glinides),
- dipeptidyl peptidase-4 (DPP-4) inhibitors,
- Sodium-glucose co-transporter-2 (SGLT2) inhibitors,
- Alpha-glucosidase inhibitors,
- Oral combination products (for the allowed individual oral anti-diabetic drugs),
- Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists
- Body mass index (BMI) equal to or below 40.0 kg/m^2.
- 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