Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents

A Philis-Tsimikas, S Del Prato, I Satman, A Bhargava, M Dharmalingam, T V Skjøth, S Rasmussen, A J Garber, A Philis-Tsimikas, S Del Prato, I Satman, A Bhargava, M Dharmalingam, T V Skjøth, S Rasmussen, A J Garber

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: 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.

Keywords: efficacy; insulin degludec; safety; sitagliptin; type 2 diabetes.

© 2013 John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Patient flow. ‘Other’ included subjects who withdrew consent, subjects who relocated, subjects who were lost to follow-up and subjects who discontinued due to meeting withdrawal criteria. AE, adverse event; FAS, full analysis set; IDeg, insulin degludec; OD, once daily; SAS, safety analysis set; Sita, sitagliptin.
Figure 2
Figure 2
Mean glycosylated haemoglobin (HbA1c) (A) and fasting plasma glucose (FPG) (B) during 26 weeks of treatment. IDeg, insulin degludec; Sita, sitagliptin.
Figure 3
Figure 3
Nine-point self-measured plasma glucose profile. IDeg, insulin degludec; Sita, sitagliptin.

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