From 1 December 2013 the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin will join the other gliptins already listed on thePBS — sitagliptin (Januvia), vildagliptin (Galvus), saxagliptin (Onglyza) and linagliptin (Trajenta).

Alogliptin (25 mg, 12.5 mg and 6.25 mg) is a treatment option for dual oral therapy in combination with either metformin or a sulfonylurea for people with type 2 diabetes who are not adequately controlled with either drug alone.1

PBS listing restrictions

The Authority required (Streamlined) listing of alogliptin permits use in dual oral combination therapy with metformin or a sulfonylurea in people with type 2 diabetes whose HbA1c is > 7% (53 mmol/mol) despite treatment with either metformin or a sulfonylurea. Alogliptin may be prescribed by nurse practitioners.1

The subsidised use of alogliptin is similar to that for the other DPP-4 inhibitors. However, the PBS listing of alogliptin permits its use as an add-on to metformin without using a sulfonylurea first. It is the first DPP-4 inhibitor to receive this PBS listing for use in patients without contraindication or intolerance to a combination of metformin and a sulfonylurea.

Efficacy is similar across the class of gliptins

Alogliptin, sitagliptin, vildagliptin, saxagliptin and linagliptin all improve glycaemic control in diabetes not adequately controlled with metformin or a sulfonylurea.

When combined with metformin, alogliptin appears to provide improvements in HbA1c similar to those with the other gliptins. However, no head-to-head trials have compared the efficacy of alogliptin with other gliptins or any of the other available anti-diabetic drugs.

In several large trials of up to 26 weeks' duration, oral alogliptin in combination with other oral glucose-lowering agents (metformin, glyburide or pioglitazone)2-4 improved glycaemic control and was generally well tolerated in people with inadequately controlled type 2 diabetes.

For people on oral antihyperglycaemic agents (metformin, glyburide or pioglitazone), the mean least squares (LS) changes in HbA1c from baseline to week 26 were significantly reduced (p < 0.001) with addition of alogliptin compared with placebo (Table 1).2-4

Table 1 Mean LS change in HbA1c from baseline to week 26 2-4

Antihyperglycaemic agent

(25 mg)











Alogliptin has similar advantages to those of the other DPP-4 inhibitors for some people with type 2 diabetes. As add-on therapy it may be a useful alternative to a sulfonylurea, a glitazone, a glitinide* or insulin for people who are overweight or at high risk of hypoglycaemia. Alogliptin is associated with a similar incidence of hypoglycaemia to that of placebo and has a weight-neutral effect.5

*Please note that there are currently no glitinides available in Australia; for further information refer to our Medicines and treatments pages about Repaglinide.

What to consider before prescribing

Alogliptin is well tolerated and has a good safety profile.2-4 However, the long-term safety profile of the gliptins is yet to be established. A long-term, open-label extension study that investigated the safety of alogliptin in people with type 2 diabetes has been completed, but the results have not been published as yet.6

A recent clinical trial investigated the CV safety of alogliptin (n = 2701) versus placebo (n = 2679) in addition to standard care. In people with type 2 diabetes who had a recent acute coronary syndrome, no increase in rates of adverse CV outcomes (including CV death, and non-fatal MI or stroke) were seen for alogliptin compared with placebo.7 But the long-term CV impact of alogliptin is yet to be determined.

The recommended dose of alogliptin is 25 mg once daily as add-on therapy to metformin or a sulfonylurea. No dose reduction is recommended when alogliptin is used in combination with metformin and/or a thiazolidinedione. When alogliptin is used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycaemia.8

Reduce alogliptin dose in patients with eGFR 30–50 mL/min to 12.5 mg and in patients with eGFR < 30 mL/min to 6.25 mg. Alogliptin is not recommended for use in patients with severe hepatic impairment.8

For further information

For more information on the use of gliptins for the treatment of type 2 diabetes refer to the full NPS RADAR review onsitagliptin, vildagliptin and saxagliptin (published July 2011)9 or the brief item on linagliptin (published March 2012).10


  1. Australian Government Department of Health and Ageing. July 2013 PBAC Outcomes – Positive Recommendations. 2013. (accessed 30 August 2013).
  2. Nauck MA, Ellis GC, Fleck PR, et al. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009;63:46–55. [PubMed]
  3. Pratley RE, Kipnes MS, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009;11:167–76. [PubMed]
  4. Pratley RE, Reusch JE, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009;25:2361–71. [PubMed]
  5. Scott LJ. Alogliptin: a review of its use in the management of type 2 diabetes mellitus. Drugs 2010;70:2051–72. [PubMed]
  6. Takeda Global Research and Development Center Inc. A long-term, open-label extension study to investigate the long-term safety of SYR110322 (SYR-322) in subjects with type 2 diabetes. identifier NCT00306384: US National Institutes of Health, 2013. (accessed 24 September 2013).
  7. White WB, Cannon CP, Heller SR, et al. Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes. N Engl J Med 2013; 369:1327–35. [PubMed]
  8. Takeda Pharmaceuticals Australia Pty Ltd. Nesina Product Information. 2013; 8 October 2013).
  9. National Prescribing Service Limited. Sitagliptin, vildagliptin and saxagliptin — dipeptidyl peptidase-4 inhibitors ('gliptins') add-on therapy in type 2 diabetes mellitus. NPS RADAR, July 2011. (accessed 2 August 2013).
  10. National Prescribing Service Limited. Another dipeptidyl peptidase-4 inhibitor ('gliptin') for add-on therapy in type 2 diabetes mellitus. NPS RADAR 2012. (accessed 5 August 2013).