David R Owens1, Geremia B Bolli2, Bernard Charbonnel3, Thomas Haak4, Wolfgang Landgraf5, Francesca Porcellati2, Louise Traylor6, Alexandra Kautzky-Willer7. 1. Diabetes Research Group, Institute of Life Sciences, College of Medicine, Swansea University, Swansea, UK. 2. Department of Medicine, University of Perugia School of Medicine, Perugia, Italy. 3. University of Nantes, Nantes, France. 4. Diabetes Center Mergentheim, Bad Mergentheim, Germany. 5. Sanofi, Frankfurt, Germany. 6. Sanofi US, Inc., Bridgewater, New Jersey. 7. Department of Endocrinology and Diabetes, Gender Medicine, Medical University of Vienna, Vienna, Austria.
Abstract
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 100U/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 plussulfonylurea (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 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/m2 ) 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/m2 , 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/m2 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.
RCT Entities:
AIMS: To analyse the effects of patient characteristics and different oral antidiabetes drug (OAD) use on standardised clinical outcomes in type 2 diabetespatients 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 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/m2 ) 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/m2 , 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/m2 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.
Authors: Geremia B Bolli; Wolfgang Landgraf; Zsolt Bosnyak; Lydie Melas-Melt; Philip D Home Journal: Diabetes Obes Metab Date: 2020-05-29 Impact factor: 6.577
Authors: David R Owens; Wolfgang Landgraf; Brian M Frier; Mei Zhang; Philip D Home; Luigi Meneghini; Geremia B Bolli Journal: Diabetes Obes Metab Date: 2019-02 Impact factor: 6.577