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)
• •Systemic or intra-articular corticosteroids treatment within the last 3 months.