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EASD: Pioglitazone-Sitagliptin Combination Achieves Durable Glycemic Control

Posted: Sunday, October 03, 2010

Adding 50 mg of sitagliptin (Januvia) to pioglitazone (Actos) allowed patients with Type 2 diabetes to achieve sustained glycemic control, a yearlong trial showed.

The 52-week data from Japan -- 40 weeks of which were an open-label extension of a 12-week double blind trial -- confirmed the efficacy of the sitagliptin/pioglitazone combination that has been observed in shorter trials, said Bernard Charbonnel, M.D., of University Hospital of Nantes in France.

Dr. Charbonnel, who was not involved in the study, discussed the findings of the 134-patient trial at a press briefing at the European Association for the Study of Diabetes meeting. At baseline, the patients enrolled in the 12-week trial had a hemoglobin A1c of 6.5% to 10%. The researchers randomized 66 patients to the sitagliptin/pioglitazone arm and 68 to placebo/pioglitazone.

After 12 weeks, sitagliptin was associated with a mean HbA1c that was 0.8% lower than patients in the control group, which was significant at P<0.001. The patients also showed significant improvements in fasting plasma glucose, two-hour postprandial glucose, and beta cell function relative to placebo (P<0.001 for all).

Fifty patients randomized to sitagliptin/pioglitazone completed the 40-week open-label extension, said Hiroshi Maegawa, M.D., Ph.D., of Shiga University of Medical Science. After 52 weeks, the mean change in HbA1c from baseline was -0.7% and 62% of patients had achieved HbA1c of less than 7%; 28% of patients had HbA1c levels of less than 6.5%.

There was no increase in hypoglycemia.

But there was a small, not statistically significant increase in body weight -- 0.76 kg (1.7 lbs.) -- for patients who were treated for 52 weeks with the sitagliptin/pioglitazone combination.

Practice Pearls:

* Explain to interested patients that this study suggests that adding sitagliptin to pioglitazone appears to improve glycemic control but does not increase the risk of hypoglycemia.
* Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Source: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9870&catid=53&Itemid=8, Maegawa H, et al "Sitagliptin added to ongoing treatment with pioglitazone study up to 52 weeks in Japanese patients with T2DM" EASD 2008; Abstract 910.