title: Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents.
abstract: OBJECTIVE
  The efficacy and safety of insulin degludec (IDeg), a new basal insulin with an ultra-long duration of action, was compared to sitagliptin (Sita) in a 26-week, open-label trial.
  
  
  METHODS
  Insulin-naïve subjects with type 2 diabetes [n = 458, age: 56 years, diabetes duration: 7.7 years, glycosylated haemoglobin (HbA1c): 8.9% (74 mmol/mol)] were randomized (1 : 1) to once-daily IDeg or Sita (100 mg orally) as add-on to stable treatment with 1 or 2 oral antidiabetic drugs (OADs).
  
  
  RESULTS
  Superiority of IDeg to Sita in improving HbA1c and fasting plasma glucose (FPG) was confirmed [estimated treatment difference (ETD) IDeg-Sita for HbA1c: -0.43%-points [95% confidence interval (CI): -0.61; -0.24, p < 0.0001] and for FPG: -2.17 mmol/l (95% CI: -2.59; -1.74, p < 0.0001)]. HbA1c < 7% (<53 mmol/mol) was achieved by 41% (IDeg) versus 28% (Sita) of patients, estimated odds ratio IDeg/Sita: 1.60 (95% CI: 1.04; 2.47, p = 0.034). There was no statistically significant difference in the rate of nocturnal confirmed hypoglycaemia between IDeg and Sita [0.52 vs. 0.30 episodes/patient-year, estimated rate ratio (ERR): IDeg/Sita: 1.93 (95% CI: 0.90; 4.10, p = 0.09)]. Rates of overall confirmed hypoglycaemia were higher with IDeg than with Sita [3.1 vs. 1.3 episodes/patient-year, ERR IDeg/Sita: 3.81 (95% CI: 2.40; 6.05, p < 0.0001)]. IDeg was associated with a greater change in body weight than Sita [ETD IDeg-Sita: 2.75 kg (95% CI: 1.97; 3.54, p < 0.0001)]. The overall rates of adverse events were low and similar for both groups.
  
  
  CONCLUSIONS
  In patients unable to achieve good glycaemic control on OAD(s), treatment intensification with IDeg offers an effective, well-tolerated alternative to the addition of a second or third OAD.
authors.affiliation: Scripps Whittier Diabetes Institute, San Diego, CA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Philis-Tsimikas
authors.forename: S
authors.initials: S
authors.lastname: Del Prato
authors.forename: I
authors.initials: I
authors.lastname: Satman
authors.forename: A
authors.initials: A
authors.lastname: Bhargava
authors.forename: M
authors.initials: M
authors.lastname: Dharmalingam
authors.forename: T V
authors.initials: TV
authors.lastname: Skjøth
authors.forename: S
authors.initials: S
authors.lastname: Rasmussen
authors.forename: A J
authors.initials: AJ
authors.lastname: Garber
mesh_terms: D000284:Administration, Oral; D001118:Argentina / Q000453:epidemiology; D001786:Blood Glucose / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D002170:Canada / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004334:Drug Administration Schedule; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects*; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007194:India / Q000453:epidemiology; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008297:Male; D008800:Mexico / Q000453:epidemiology; D008875:Middle Aged; D011719:Pyrazines / Q000627:therapeutic use*; D000068900:Sitagliptin Phosphate; D013019:South Africa / Q000453:epidemiology; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D014421:Turkey / Q000453:epidemiology; D014481:United States / Q000453:epidemiology
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D011719:Pyrazines; D000068900:Sitagliptin Phosphate; D014230:Triazoles; C517652:hemoglobin A1c protein, human; C571886:insulin degludec
keywords: efficacy; insulin degludec; safety; sitagliptin; type 2 diabetes