Effects of age, gender, and body mass index on efficacy and hypoglycaemia outcomes across treat-to-target trials with insulin glargine 100 U/mL added to oral antidiabetes agents in type 2 diabetes

Aims: To analyse the effects of patient characteristics and different oral antidiabetes drug (OAD) use on standardised clinical outcomes in type 2 diabetes patients initiating insulin glargine 100 U/mL (Gla-100). Materials and methods: Patient-level data from 16 randomized, treat-to-target clinical trials that added Gla-100 to existing metformin (MET), sulfonylurea (SU) or metformin plus sulfonylurea (MET + SU) treatment in insulin-naive patients inadequately controlled by oral therapy were analysed and patients were followed for >= 24 weeks. Change in glycated haemoglobin A1c (HbA1c) from baseline to week 24, other glycaemic endpoints and incidence of hypoglycaemia (overall, nocturnal, and severe) were analysed by age (< 65 vs >= 65 years), gender (male vs female), body mass index (BMI; < 25 vs >= 25 to < 30 vs > 30 kg/m(2)) and concomitant OAD (MET vs SU vs MET+ SU). Results: At baseline, the overall population (N = 3188) had a mean age of 57.7 years, BMI of 30.5 kg/m(2), HbA1c of 8.7%, fasting plasma glucose of 192 mg/dL, and 52.7% were male. Younger and older patients had similar HbA1c reductions with Gla-100 and a similar risk of hypoglycaemia. Females and patients with BMI < 25 kg/m(2) were less likely to achieve HbA1c targets and more likely to experience hypoglycaemia, regardless of concomitant OAD. Adding Gla-100 to SU therapy (alone or in combination with MET) increased hypoglycaemia risk across all analyses. Conclusions: Our data suggest that female patients with type 2 diabetes and normal-weight patients treated with Gla-100 and MET +/- SU are less likely to achieve glycaemic targets and, therefore, may require more clinical attention. Addition of Gla-100 to SU regimens may increase hypoglycaemia risk irrespective of age, gender, or BMI.