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Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents
Author(s) -
PhilisTsimikas A.,
Del Prato S.,
Satman I.,
Bhargava A.,
Dharmalingam M.,
Skjøth T. V.,
Rasmussen S.,
Garber A. J.
Publication year - 2013
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12115
Subject(s) - insulin degludec , sitagliptin , medicine , type 2 diabetes , diabetes mellitus , insulin , endocrinology , sitagliptin phosphate , insulin glargine
Aim 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 .