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: 56years, diabetes duration: 7.7years, glycosylated haemoglobin (HbA1c): 8.9% (74mmol/mol)] were randomized (1:1) to once-daily IDeg or Sita (100mg 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% (<53mmol/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: 2.75kg (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. © 2013 John Wiley & Sons Ltd.
Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents
DEL PRATO, STEFANO;
2013-01-01
Abstract
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: 56years, diabetes duration: 7.7years, glycosylated haemoglobin (HbA1c): 8.9% (74mmol/mol)] were randomized (1:1) to once-daily IDeg or Sita (100mg 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% (<53mmol/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: 2.75kg (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. © 2013 John Wiley & Sons Ltd.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
