The relationship between mild (MH) and severe hypoglycemia (SH) has been quantitatively evaluated in a randomized controlled, open-label, 2-arm, parallel study, in 2008 patients with type 2 diabetes initiating insulin (insulin glargine or insulin lispro mixture 25/75). Standard definitions were used for MH (all non-SH) and SH. A Cox regression model was employed to identify risk factors associated with incident SH. Average age was 56.90 (9.82) years, diabetes duration was 9.54 (6.10) years, BMI was 31.68 (5.96) kg/m2 and HbA1c was 9.03 (1.26)%. During a treatment period of 24 weeks, 78.6% (1606/2043) of the patients experienced more than one MH - but no SH - with a mean monthly MH rate (SD) of 2.67 (2.98). Thirty-three of 2043 patients (1.6%) experienced at least one SH with a mean monthly MH rate (SD) of 5.11 (3.98). Among all factors tested in the model, only the monthly MH rate (HR=1.174, CI [1.106, 1.248], p-value1.05) (Figure Presented).
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