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Lantus® was evaluated for 52 weeks in insulin-naive adult patients with type 2 diabetes on OADs

A1C decreased by

1.5%

in the Lantus® and insulin detemir treatment groups and was comparable among groups after 52 weeks (7.1% for Lantus® and 7.2% for insulin detemir)

52% of participants in the study achieved A1C ≤7%

100% of Lantus® patients were dosed once a day throughout the study

Safety results

Study Design

An open-label, parallel-group, noninferiority trial of 582 insulin-naive patients with type 2 diabetes. Patients were randomized 1:1 to receive Lantus® (n=291) or insulin detemir (n=291) once daily (in the evening) as add-on therapy to oral glucose-lowering drugs. Both insulins were titrated to an FPG target of ≤108 mg/dL. An additional morning insulin dose of insulin detemir was allowed if pre-dinner PG was >126 mg/dL, but only if pre-breakfast PG was <126 mg/dL or nocturnal hypoglycemia (major episode or PG ≤72 mg/dL) precluded achievement of the FPG target. Participants were eligible if A1C ranged from 7.5% to 10%. Primary endpoint was change in A1C at end of treatment period.