title: Efficacy and safety of linagliptin as add-on therapy to basal insulin and metformin in people with Type 2 diabetes.
abstract: To evaluate the efficacy and safety of linagliptin in people with Type 2 diabetes inadequately controlled on basal insulin and metformin.
  
  
  
  This was a post hoc subanalysis of participants who received basal insulin and metformin in a global phase III study that randomized participants (1:1) to receive linagliptin 5 mg once daily or placebo for ≥52 weeks as add-on therapy to basal insulin alone or in combination with metformin and/or pioglitazone. During the first 24 weeks, the background dose of basal insulin remained stable; thereafter, adjustments based on glucose concentrations were recommended. The primary endpoint of the subanalysis was the change from baseline in HbA1c after 24 weeks. The safety analysis incorporated data up to a maximum of 110 weeks.
  
  
  
  A total of 950 participants receiving background insulin and metformin were included in this subanalysis (linagliptin and placebo, both n = 475). At week 24, the placebo-corrected adjusted mean (±se) change from baseline in HbA1c with linagliptin was -7 (±1) mmol/mol [-0.7 (±0.1) %; 95% CI -0.8, -0.6; P < 0.0001]. The overall frequency of drug-related adverse events (linagliptin, 18.9%; placebo, 21.9%) and investigator-reported hypoglycaemia (linagliptin, 30.7%; placebo, 31.6%) were similar in both groups at the end of treatment. The frequency of severe hypoglycaemia was low (linagliptin, 1.7%; placebo, 0.8%). No meaningful changes in mean (±sd) body weight were noted in either group [week 52: linagliptin, -0.5 (±3.2) kg; placebo, 0.0 (±3.1) kg].
  
  
  
  Linagliptin added to basal insulin and metformin improved glycaemic control, without increasing the risk of hypoglycaemia or body weight gain.
authors.affiliation: Valme University Hospital Medical School, Seville, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Durán-Garcia
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Medicine, University of Helsinki, Helsinki, Finland.
authors.forename: H
authors.initials: H
authors.lastname: Yki-Järvinen
authors.affiliation: Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.
authors.forename: J
authors.initials: J
authors.lastname: Rosenstock
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Hehnke
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Thiemann
authors.affiliation: Boehringer Ingelheim Ltd, Bracknell, UK.
authors.forename: S
authors.initials: S
authors.lastname: Patel
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Woerle
mesh_terms: D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D000069476:Linagliptin / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome; D015430:Weight Gain; D015431:Weight Loss
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069476:Linagliptin; D008687:Metformin; C517652:hemoglobin A1c protein, human