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Results of new exploratory analyses assessing the incidence of hypoglycemia with linagliptin in adults with type 2 diabetes announced
Date:6/22/2013

igher with glimepiride versus linagliptin in each quartile of HbA1c change from baseline (all p<0.0001). The percentage of people who experienced hypoglycemia was not increased with greater reductions in HbA1c in either group. In all four-week intervals, the percentage of people who experienced a hypoglycemic event was lower with linagliptin versus glimepiride.1

About the Studies
Findings from the first exploratory analysis of data on elderly people with T2D (n=247; mean age, 74 years; baseline HbA1c, 8.2 percent) who had linagliptin or placebo added onto basal insulin therapy (baseline dose 36 U/day) from two phase III studies of 24 and > 52 weeks. The analysis measured the relative ORs for overall and confirmed hypoglycemia (the latter defined as blood glucose < 70 mg/dL). The insulin doses did not change notably throughout the trials.1

The findings from the second analysis are based on two-year data from a randomized, double-blind study of linagliptin 5 mg qd (n=777) versus glimepiride 1 mg to 4 mg qd (n=775) in people with T2D previously uncontrolled with metformin therapy.2 The study showed comparable reductions in HbA1c between the two treatments.2 For the exploratory analysis, the risk of investigator-reported hypoglycemia for linagliptin was compared with glimepiride based on dose, over time, and by HbA1c reduction. People randomized to glimepiride started treatment on 1 mg. Those who did not achieve a fasting plasma glucose level of 110 mg/dL at 4 weeks and who were not at hypoglycemia risk were subsequently uptitrated stepwise up to a maximum of 4 mg qd.2

Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily 5 mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Linagliptin should not be u
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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