Age, BMI and Diabetes Duration: Effect on Glycaemic Control and Hypoglycaemia with Insulin Glargine 300 U/mL in Type 2 Diabetes — ASN Events
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Age, BMI and Diabetes Duration: Effect on Glycaemic Control and Hypoglycaemia with Insulin Glargine 300 U/mL in Type 2 Diabetes (#165)

Stephen Twigg 1 , Javier Escalada 2 , Marie-Lise Grisoni 3 , Peter Stella 4 , Ana Merino-Trigo 4 , Fernando J Lavalle González 5 , Bertrand Cariou 6 , Luigi F Meneghini 7
  1. Dept of Endocrinology, Royal Prince Alfred Hospital, Sydney Medical School, University of Sydney, Sydney, NSW, Australia
  2. Dept of Endocrinology and Nutrition, Clínica Universidad de Navarra, Pamplona, Spain
  3. Aixail, Levallois-Perret, France
  4. Sanofi, Paris, France
  5. Universidad Autonoma de Nuevo Leon, Monterrey, Mexico
  6. Dept of Endocrinology, University Hospital of Nantes, Nantes, France
  7. Division of Endocrinology, University of Texas Southwestern Medical Center, Dallas, Texas, USA

The EDITION 1, 2 and 3 clinical trials (NCT01499082, NCT01499095, NCT01676220) showed that insulin glargine 300 U/mL (Gla-300) provided comparable glycaemic control to glargine 100 U/mL (Gla-100) and less hypoglycaemia in people with type 2 diabetes, over 6 months of treatment. We conducted a post hoc patient-level meta-analysis of EDITION 1, 2 and 3 data to evaluate the effects of Gla-300 versus Gla-100 on HbA1c reduction and hypoglycaemia in different subgroups (age [<65 and ≥65 years], BMI [<30 and ≥30 kg/m2] and diabetes duration [<10 and ≥10 years]).

For glycaemic control, the heterogeneity of treatment effect was evaluated using a mixed model of repeated measurements analysis, with subgroup, study, subgroup-by-treatment, subgroup-by-visit and subgroup-by-treatment-by-visit interactions as fixed effects. For hypoglycaemia, this evaluation was based on a logistic model with subgroup, treatment, study, randomization strata of screening HbA1c (<8.0 and ≥8.0%) and the interaction subgroup-by-treatment as fixed effects.

Mean HbA1c reduction over 6 months of treatment remained comparable between the Gla-300 and Gla-100 arms, regardless of age (p=0.954), BMI (p=0.665) or disease duration (p=0.067). The proportion of participants experiencing one or more confirmed (≤70 mg/dL [≤3.9mmol/L]) or severe hypoglycaemic events over 6 months of treatment was lower with Gla-300 versus Gla-100. Neither hypoglycaemia at any time of day nor nocturnal (00:00-05:59) hypoglycaemia was affected by age or BMI.

For the diabetes duration subgroup analysis no significant heterogeneity of treatment effect was seen for nocturnal hypoglycaemia (p=0.109), whereas the benefit of lower risk of confirmed (≤70 mg/dL [≤3.9mmol/L]) or severe hypoglycaemia at any time of day with Gla-300 was seen in those with longer duration of diabetes (p=0.006).

In conclusion, comparable glycaemic control was observed with Gla-300 and Gla-100, and less nocturnal hypoglycemia was seen for Gla-300 regardless of the subgroup.

Disclosures: This analysis was funded by Sanofi. Editorial assistance (Scriptix Pty Ltd) was funded by Sanofi Australia Pty Ltd. Data first presented at the American Diabetes Association 75th Scientific Sessions, June 5-9 2015, Boston, MA, USA