title: Relationship of body mass index with efficacy of exenatide twice daily added to insulin glargine in patients with type 2 diabetes.
abstract: This post hoc analysis assessed the evidence behind common reimbursement practices by evaluating the relationship of body mass index (BMI) ranges (<30, 30-35 and >35 kg/m(2) ) with treatment effects of exenatide twice daily among patients with type 2 diabetes. Patients received exenatide twice daily added to insulin glargine in two 30-week studies (exenatide twice daily vs insulin lispro, n = 627; exenatide twice daily vs placebo, n = 259). No association of baseline BMI with changes in efficacy variables was observed. Glycated haemoglobin (HbA1c) reductions were significant (p < 0.0001) and similar across BMI range groups in the lispro-comparator study and greater for exenatide versus placebo in the placebo-controlled study. Significant weight loss occurred with exenatide across BMI range groups (p < 0.0001), while weight increased with both comparators. Achievement of HbA1c <7.0% (<53 mmol/mol) without weight gain was greater for exenatide versus comparators. Systolic blood pressure decreased across BMI range groups with exenatide in the lispro-comparator study (p < 0.0001); changes in lipids were not clinically meaningful. Minor hypoglycaemia was less frequent for exenatide versus insulin lispro. These findings suggest that BMI alone should not limit clinical decision-making or patient access to medication.
authors.affiliation: Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: B H R
authors.initials: BH
authors.lastname: Wolffenbuttel
authors.affiliation: Department of Endocrinology, Diabetology, and Metabolism, Antwerp University Hospital, Antwerp, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Van Gaal
authors.affiliation: Unidad de Gestion de Endocrinología y Nutrición, Hospital Universitario Virgen de Valme, Seville, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Durán-Garcia
authors.affiliation: Pharmapace, Inc, San Diego, CA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Han
mesh_terms: D000368:Aged; D015992:Body Mass Index; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D004359:Drug Therapy, Combination; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D000069036:Insulin Glargine / Q000627:therapeutic use*; D061268:Insulin Lispro / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000378:metabolism*; D010455:Peptides / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014688:Venoms / Q000627:therapeutic use*
chemical_list: D000077270:Exenatide; D006442:Glycated Hemoglobin; D000069036:Insulin Glargine; D061268:Insulin Lispro; D010455:Peptides; D014688:Venoms; C517652:hemoglobin A1c protein, human
keywords: body mass index; exenatide twice daily; type 2 diabetes