Intervention: Basaglar
Trial phase: Phase 3
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Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 360
Group description: Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to <5.5 mmol/L (71- <100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years or older at the time of signing informed consent
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criteria:

Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
History of chronic or idiopathic acute pancreatitis
Screening calcitonin value greater than or equal to 50 ng/L
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Acute coronary or cerebrovascular event within 90 days before randomisation
Heart failure, New York Heart Association Class IV
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures