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Pooled data underlines efficacy of linagliptin in treating Type II diabetes

By jeremyc | February 22, 2012

A recent pooled data analysis shows that dipeptidyl peptidase (DPP)-4 inhibitor linagliptin is a well tolerated drug for patients with Type 2 diabetes. The research was conducted by a group of researchers headed by Guntram Schernthaner at Rudolfstiftung Hospital in Austria.

The probability of occurrence of adverse affects was the similar for patients on placebo as well as patients on linagliptin, and so were the rates of treatment discontinuation. “There were no substantial differences in the incidence of most individual AEs with linagliptin therapy compared with placebo,” said Guntram Schernthaner.

The research was conducted as a part of phase III trials. Even though the phase II and III trials have proved the efficacy of the drug, the pooled data further added on to the results. The trial that lasted for 12-24 weeks analyzed the adverse events (AEs) reported by patients who took 5mg linagliptin once in a day as against the same amount of placebo. The research was conducted in eight randomized, placebo controlled environment. The researchers assessed the tolerability and safety of the drug in 3572 Type II diabetic patients. The research team has defined a serious case of AE as an event that is life threatening and that result in hospitalization, birth defect and significant disability.

The results showed that the AE incidents of both linagliptin and placebo were the same at 55.8 per cent and 55.0 per cent. The results also found that the incidents of serious AEs was also almost the same with 2.8 per cent and 2-7 cases reported for placebo and linagliptin respectively.

However, higher rates of hypoglycemia were reported by those who took linagliptin as the figures stood at 8.2 per cent as against 5.3 per cent of placebo. It was also found that 96 per cent of hypoglycemia was reported from 38 per cent patients who have sulfonylurea therapy.

After analyzing the results, the researchers have decided to reduce the dose of sulfonylurea background therapy. The researchers are continuing the assessment and monitoring of AEs so that they can come up with a fool proof profile for linagliptin.

Topics: | Diabetes |

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