Once-daily prandial lixisenatide versus once-daily rapid-acting insulin in patients with type 2 diabetes mellitus insufficiently controlled with basal insulin: analysis of data from five randomized, controlled trials.
OBJECTIVE
To compare the efficacy and safety of lixisenatide (LIXI), a once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist, as add-on to basal insulin (Basal+LIXI) versus once-daily rapid-acting insulin (Basal+RAI) in patients with type 2 diabetes mellitus (T2DM).


METHODS
Data were extracted from five randomized controlled trials assessing the efficacy and safety of basal insulin+insulin glulisine (n=3) or basal insulin+LIXI (n=2). Patients in the Basal+LIXI cohort were matched to patients in the Basal+RAI cohort using propensity score matching.


RESULTS
In the matched population, Basal+LIXI was twice as likely to reach composite outcomes of glycated haemoglobin (HbA1c) <7% and no symptomatic hypoglycaemia compared with the Basal+RAI group (odds ratio [OR]: 1.90; 95% confidence interval [CI]: 1.01, 3.55; P=0.0455), as well as HbA1c <7% and no severe hypoglycaemia (OR: 1.97; 95 CI: 1.06, 3.66; P=0.0311). Furthermore, Basal+LIXI was more than twice as likely to reach HbA1c <7%, no weight gain and no symptomatic hypoglycaemia (OR: 2.58; 95% CI: 1.23, 5.40; P=0.0119).


CONCLUSIONS
Both basal+LIXI and Basal+RAI improved glycaemic control in patients with T2DM with inadequate glycaemic control on basal insulin. Basal+LIXI offers an effective therapeutic option to advance basal insulin therapy, improving glucose control without weight gain and with less risk of hypoglycaemia than prandial insulin.
University Hospital Sainte Marguerite, Marseille, France. Electronic address: denis.raccah@ap-hm.fr.
Denis
D
Raccah
Outcomes Research, Novosys Health, Flemington, NJ, USA.
Jay
J
Lin
Diabetes-Metabolism Franchise, Sanofi-Aventis US, Bridgewater, NJ, USA.
Edward
E
Wang
Diabetes-Metabolism Franchise, Sanofi, Paris, France.
Maeva
M
Germé
Diabetes-Metabolism Franchise, Sanofi, Paris, France.
Riccardo
R
Perfetti
University of Verona Medical School and Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy.
Riccardo C
RC
Bonadonna
Dr Negrin Hospital, Las Palmas University, Las Palmas, Spain.
Pedro
P
de Pablos-Velasco
Department of Diabetology, Endocrinology and Nutrition, Assistance Publique Hôpitaux de Paris, Bichat Hospital, Paris, France; INSERM, Research Unit 872, Paris, France; University Paris Diderot, Sorbonne Paris Cité, UFR de Médecine, Paris, France.
Ronan
R
Roussel
Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.
Julio
J
Rosenstock
D000368:Aged; D016022:Case-Control Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D061266:Insulin, Short-Acting / Q000008:administration & dosage*; D008297:Male; D062407:Meals; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D017211:Treatment Failure; D000067758:Glucagon-Like Peptide-2 Receptor
D006442:Glycated Hemoglobin; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; D061266:Insulin, Short-Acting; D010455:Peptides; C517652:hemoglobin A1c protein, human; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
Basal insulin; Basal+RAI; GLP-1 receptor agonist; Lixisenatide