title: One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin.
abstract: Greater reductions in glycated haemoglobin (HbA1c) with saxagliptin, a dipeptidyl peptidase-4 inhibitor, versus placebo add-on in patients with type 2 diabetes who had inadequate glycaemic control with dapagliflozin 10 mg/d plus metformin were demonstrated after 24 weeks of treatment. Results over 52 weeks of treatment were assessed in this analysis.
  
  
  
  Patients (mean baseline HbA1c 7.9%) receiving open-label dapagliflozin 10 mg/d plus metformin were randomized to double-blind saxagliptin 5 mg/d or placebo add-on.
  
  
  
  The adjusted mean change from baseline to week 52 in HbA1c was greater with saxagliptin than with placebo add-on -0.38% vs 0.05%; difference -0.42% (95% confidence interval -0.64, -0.20)]. More patients achieved the HbA1c target of <7% with saxagliptin than with placebo add-on (29% vs 13%), and fewer patients were rescued or discontinued the study for lack of glycaemic control with saxagliptin than with placebo add-on (19% vs 28%). Reductions from baseline in body weight (≤1.5 kg) occurred in both groups. Similar proportions of patients reported ≥1 adverse event with saxagliptin (58.2%) and placebo add-on (58.0%); no new safety signals were detected. Hypoglycaemia was infrequent in both treatment groups (≤2.5%), with no major episodes. The rate of urinary tract infections was similar in the saxagliptin and placebo add-on groups (7.8% vs 7.4%). The incidence of genital infections was 3.3% with saxagliptin versus 6.2% with placebo add-on.
  
  
  
  Triple therapy with saxagliptin add-on to dapagliflozin plus metformin for 52 weeks resulted in sustained improvements in glycaemic control without an increase in body weight or increased risk of hypoglycaemia.
authors.affiliation: Diabetes-Zentrum, Quakenbrück Hospital, Quakenbrück, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Matthaei
authors.affiliation: Aggarwal and Associates, Ltd, Brampton, Ontario, Canada.
authors.forename: N
authors.initials: N
authors.lastname: Aggarwal
authors.affiliation: Servicio de Endocrinologia, Hospital Universitario Dr. José Eleuterio Gonzalez, Monterrey, Nuevo Leon, Mexico.
authors.forename: P
authors.initials: P
authors.lastname: Garcia-Hernandez
authors.affiliation: Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, USA. nayyar.iqbal@astrazeneca.com.
authors.forename: N
authors.initials: N
authors.lastname: Iqbal
authors.affiliation: Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, USA.
authors.forename: H
authors.initials: H
authors.lastname: Chen
authors.affiliation: Global Medicines Development, AstraZeneca, Gothenburg, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Johnsson
authors.affiliation: Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, USA.
authors.forename: A
authors.initials: A
authors.lastname: Chin
authors.affiliation: Global Clinical Research Metabolics, Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: L
authors.initials: L
authors.lastname: Hansen
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000368:Aged; 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 / Q000188:drug therapy; D004151:Dipeptides / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005960:Glucosides / Q000008:administration & dosage* / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced; 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
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; 
  SGLT-2 inhibitor; dapagliflozin; metformin; type 2 diabetes