A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine

Inclusion Criteria

• •Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• •Aged 40-75 years (both inclusive) at the time of signing informed consent.
• •Diagnosed with diabetes mellitus, type 2 (T2DM) at least 180 days prior to the day of screening.
• •Male subject or female subject of non-childbearing potential. Non-childbearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
• •HbA1c at screening between 6.0 and 10.0%, both inclusive.
• •Treated with or without any oral antidiabetic agents including any metformin formulations, dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, alpha glucosidase inhibitors, sulfonylureas (including meglitinides). If treated with oral antidiabetic agents, the total daily dose must have been stable within the past 30 days prior to the day of screening.
• •Treated with basal insulin regimen at least 90 days prior to the day of screening with a total daily dose of:
• •equal to or above 10U/day if HbA1c above 7.5%
• •equal to or above 15U/day if HbA1c above 6.5% and equal to or below 7.5%
• •equal to or above 25U/day if HbA1c equal to or below 6.5%
• •Planned initiation of concomitant medications known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemically effective corticosteroids).
• •Use of statins (unless the use of these has been stable during the past 3 months) or use of systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products at screening.
• •Rotating or permanent night shift worker.
• •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.