Vipidia and Vipdomet: two new products for type II diabetes

Takeda has launched Vipidia and Vipdomet, two new products containing alogliptin for the treatment of type II diabetes.

Vipidia (alogliptin) is available in three strengths to allow lower daily doses to be given to patients with varying degrees of renal impairment
Vipidia (alogliptin) is available in three strengths to allow lower daily doses to be given to patients with varying degrees of renal impairment

PHARMACOLOGY

Alogliptin is a dipeptidyl peptidase 4 (DPP4) inhibitor. It is available as a single-component tablet (Vipidia) and as a fixed-dose combination tablet (Vipdomet) which also includes the biguanide oral hypoglycaemic agent, metformin.1,2

By inhibiting DPP4, alogliptin prevents degradation of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This leads to enhanced pancreatic insulin secretion and suppression of glucagon secretion, thereby reducing blood glucose levels.1

CLINICAL STUDIES

The efficacy and safety of alogliptin in combination with metformin were assessed in a 26-week double-blind study in 527 adults inadequately controlled on metformin alone who were randomised to receive metformin (≥1.5g daily) plus either alogliptin or placebo.3

Reduction in HbA1c

Significantly greater decreases in HbA1c from baseline to week 26 were observed in patients receiving alogliptin 25mg once daily compared with those given placebo (p<0.001), with significant reductions evident as early as week 4 (p<0.001 vs placebo). Alogliptin plus metformin was generally well tolerated and its safety profile did not differ greatly from that of placebo plus metformin.3

In another placebo-controlled study involving 500 adults with type II diabetes inadequately controlled on sulfonylurea monotherapy, the addition of alogliptin (25mg daily) to glibenclamide (≥5mg daily) resulted in clinically significant reductions in HbA1c without an increase in the incidence of hypoglycaemia (p≤0.001).4

Long-term efficacy and safety

The long-term efficacy and safety of alogliptin when added to metformin was compared with that of glipizide in the two-year ENDURE study involving 2,639 patients with type II diabetes inadequately controlled by metformin alone. Following a stabilisation period, patients were randomised to receive open-label metformin (≥1.5g daily or maximum tolerated dose) plus alogliptin or glipizide (5mg titrated to a maximum of 20mg daily).5

Non-inferior to glipizide

The mean change in HbA1c from baseline to week 104 was -0.72% in the alogliptin 25mg group compared with -0.59% in the glipizide group, indicating non-inferiority to glipizide. The proportion of patients who achieved HbA1c reductions to ≤7.0% and ≤6.5% at week 104 was significantly higher with alogliptin 25mg than glipizide (p<0.01). Alogliptin was well tolerated throughout the study and similar safety profiles were observed in both treatment groups, with the exception of hypoglycaemia which occurred at a greater rate in the glipizide group.5

Cardiovascular events

The cardiovascular safety profile of alogliptin was evaluated in the EXAMINE study involving 5,380 patients with type II diabetes who had either an acute myocardial infarction or unstable angina requiring hospitalisation within the previous 15 to 90 days. Participants were randomised to receive alogliptin (6.25–25mg once daily according to renal function) orplacebo in addition to standard treatment, with up to 40 months of follow-up (median 18 months).6

Analysis showed that the rates of major cardiovascular adverse events (death from cardiovascular causes, nonfatal MI or non-fatal stroke) were not increased with alogliptin compared with placebo (11.3% vs 11.8%, p<0.001 for non-inferiority).6

References:

  1. Vipidia Summary of Product Characteristics, September 2013.
  2. Vipdomet Summary of Product Characteristics, September 2013.
  3. Nauck MA et al. Int J Clin Pract 2009; 63: 46–55.
  4. Pratley RE et al. Diabetes Obes Metab 2009; 11: 167–76.
  5. Del Prato S et al. Poster presented at 73rd Scientific Session of the American Diabetes Association. Chicago, USA, June 2013; P66-LB.
  6. White WB et al. N Engl J Med 2013; 369: 1327–35.

View Vipidia drug record

View Vipdomet drug record

Further information: Takeda

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