title: Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes.
abstract: We previously reported that dapagliflozin versus placebo as add-on to saxagliptin plus metformin resulted in greater reductions in glycated haemoglobin (A1C), fasting plasma glucose (FPG) and body weight (BW) after 24 weeks of treatment in patients with type 2 diabetes (T2D). Here we report results after 52 weeks of treatment. Patients stabilized on open-label metformin and saxagliptin 5 mg/day for 8-16 weeks were randomized to placebo or dapagliflozin 10 mg/day plus open-label saxagliptin plus metformin for 52 weeks. Changes from baseline to week 52 were greater with dapagliflozin versus placebo in A1C (-0.74% vs. 0.07%), FPG (-27 vs. 10 mg/dL) and BW (-2.1 vs. -0.4 kg). More patients achieved A1C <7% with dapagliflozin (29.4%) versus placebo (12.6%). Adverse events were similar with dapagliflozin (66%) and placebo (71%), and hypoglycaemia was rare (≤2%). Genital infections occurred more often with dapagliflozin (6%) than with placebo (1%); frequency of urinary tract infections was similar between the two groups (9% vs. 10%). Triple therapy with dapagliflozin add-on to saxagliptin plus metformin is a durable, effective and well-tolerated intervention for the treatment of T2D.
authors.affiliation: Clinical and Experimental Endocrinology, Katholieke Universiteit Leuven, Leuven, Belgium. chantal.mathieu@med.kuleuven.be.
authors.forename: C
authors.initials: C
authors.lastname: Mathieu
authors.affiliation: Servicio of Endocrinologia, Torre Medica, Guadalajara, Mexico.
authors.forename: M
authors.initials: M
authors.lastname: Herrera Marmolejo
authors.affiliation: Servicio of Endocrinologia, Universidad Autónoma de Nuevo León, Monterrey, Mexico.
authors.forename: J G
authors.initials: JG
authors.lastname: González González
authors.affiliation: Global Clinical Research Metabolics, Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: L
authors.initials: L
authors.lastname: Hansen
authors.affiliation: Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, USA.
authors.forename: H
authors.initials: H
authors.lastname: Chen
authors.affiliation: Global Medicines Development, AstraZenca, Gothenburg, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Johnsson
authors.affiliation: Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, USA.
authors.forename: R
authors.initials: R
authors.lastname: Garcia-Sanchez
authors.affiliation: Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, USA.
authors.forename: N
authors.initials: N
authors.lastname: Iqbal
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004151:Dipeptides / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005960:Glucosides / Q000008:administration & dosage* / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000097:blood / Q000139:chemically induced
chemical_list: D000218:Adamantane; D001559:Benzhydryl Compounds; D001786:Blood Glucose; D004151:Dipeptides; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C529054:dapagliflozin; C502994:saxagliptin
keywords: 
  DPP-4 inhibitor; 
  SGLT2 inhibitor; dapagliflozin; metformin; type 2 diabetes