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‐naïve patients inadequately controlled by oral therapy were analysed and patients were followed for ≥24 weeks. Change in glycated haemoglobin A 1c ( HbA1c ) from baseline to w eek 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 .