A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics

Inclusion Criteria: * Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that will not have been performed during normal management of the subject.) * Age is 18-75 years * Diagnosed with Type 2 diabetes (according to the diagnosis criteria applicable locally) for at least 3 months * Treatment with one or two oral anti-diabetic drug (OADs): metformin at astable daily dose of ≥ 1500 mg or maximum tolerated dose (at least 1000mg daily), with or without insulin secretagogue (SU or glinides) or DPP-4 inhibitors or SGLT-2 inhibitors or alpha-glucosidase inhibitors for at least 8 weeks at a stable dose. The dose(s) of OAD other than metformin should be minimum half of the daily maximal dose according to local labelling or maximum tolerated dose. * Insulin naïve. short-term insulin treatment (consecutive or cumulative treatment of ≤14 days) and insulin treatment for gestational diabetes are allowed. * HbA1c 7.0-10.0 % (53-85 mmol/mol) (both inclusive) * BMI 19-40 kg/m2 (both inclusive) Exclusion Criteria: * Known or suspected allergy or intolerance to the active substance or to any of the excipients of the investigational medical products * Severe hypoglycemia during the previous 6 months. * Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months. * Cardiovascular disease within the last 12 months, defined as: stroke, decompensated heart failure (New York Heart Association \[NYHA\] class III or IV), myocardial infarction, or hospitalization for unstable angina pectoris or transient ischemic attack. * Diagnosis of malignant neoplasms (except basal cell or squamous cell skin cancer, polyps and in-situ carcinomas) within the last 5 years or increased risk of cancer or relapse of cancer. * Any antidiabetic medication other than permitted in the inclusion criteria or any weight-loss drug within the last 8 weeks.. * Systemic or intra-articular corticosteroids treatment within the last 3 months.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.