June 23, 2013
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Linagliptin reduced hypoglycemia risk vs. glimepiride

CHICAGO — Linagliptin was superior to all doses of glimepiride at all time points, regardless of HbA1c level, in reducing the risk for hypoglycemia among patients with type 2 diabetes, according to data from an exploratory analysis presented here.

Previous results of a 2-year, randomized, placebo-controlled trial demonstrated that when administered to patients with uncontrolled type 2 diabetes on metformin, linagliptin (Tradjenta, Boehringer Ingelheim) 5 mg/day (n=764) was equally as effective as glimepiride (Amaryl, Sanofi-Aventis; n=755) at reducing HbA1c levels. Moreover, treatment with linagliptin was associated with a lower risk for hypoglycemia and did not increase body weight among patients.

Patients assigned to glimepiride began at a dose of 1 mg/day; stepwise uptitration to 4 mg/day occurred among those who did not achieve a fasting plasma glucose level ≤110 mg/dL or have risk for hypoglycemia at 4 weeks.

The percentage of patients with hypoglycemia in the glimepiride group up to the maximum dose was: 1 mg, 45.0%; 2 mg, 50.8%; 3 mg, 36.1%; and 4 mg, 27.7%. During the study, more patients in the glimepiride group experienced hypoglycemia vs. those in the linagliptin group (36.1% vs. 7.5%; P<.0001). Moreover, the difference remained significant after excluding events that occurred during dose escalation (weeks 16 through 104: 25.8% vs. 5.9%; P<.0001).

In each quartile of HbA1c change from baseline, the rate of hypoglycemia was higher in patients assigned glimepiride vs. linagliptin at weeks 4, 8, 12, 16 and 104 (P<.0001). However, greater reductions in HbA1c did not increase the rate of hypoglycemia in either group. – by Stacey L. Adams

For more information:

Gallwitz B. #68-LB. Presented at: ADA Scientific Sessions; June 21-25, 2013; Chicago.

Disclosure: The researchers report no relevant financial disclosures.