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Results Of New Exploratory Analyses Assessing The Incidence Of Hypoglycemia With Linagliptin In Adults With Type 2 Diabetes Announced

RIDGEFIELD, Conn. and INDIANAPOLIS, June 22, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from two exploratory analyses assessing the risk of hypoglycemia with linagliptin treatment in adults with type 2 diabetes (T2D). 1, 2

In an exploratory analysis of data from two phase III trials, elderly people with T2D (mean age 74 years) treated with linagliptin as add-on to stable basal insulin regimen trended towards a 37 percent and 34 percent lower occurrence of overall hypoglycemia (odds ratio [OR] 0.63 [95 percent confidence interval [CI]: 0.37- 1.10]) and confirmed hypoglycemia (0.66 [0.36-1.21]), respectively, compared with people treated with placebo as add-on to basal insulin. 1 Overall hypoglycemia included all investigator-defined hypoglycemic events, while confirmed hypoglycemia was defined as blood glucose levels at or below 70 mg/dL.

In a separate exploratory analysis of two-year data from a phase III trial comparing linagliptin to glimepiride, fewer people treated with the DPP-4 inhibitor linagliptin versus the sulfonylurea glimepiride experienced hypoglycemia (7.5 percent vs. 36.1 percent; p<0.0001). 2 After excluding events during dose escalation of glimepiride (1-4 mg in weeks 0-16), a difference in those reporting hypoglycemia still remained present (5.9 percent vs. 25.8 percent; p<0.0001). The difference in the incidence of hypoglycemia between linagliptin and glimepiride was observed at all time points tested, all dose levels, and regardless of change from baseline in HbA 1c. 2 Hypoglycemia in this analysis was defined as any investigator-reported hypoglycemic event.

At weeks 4, 8, 12, 16 and 104, the percentage of people who experienced a hypoglycemic event was higher with glimepiride versus linagliptin in each quartile of HbA 1c change from baseline (all p<0.0001). The percentage of people who experienced hypoglycemia was not increased with greater reductions in HbA 1c 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 StudiesFindings from the first exploratory analysis of data on elderly people with T2D (n=247; mean age, 74 years; baseline HbA 1c, 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 HbA 1c 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 HbA 1c 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 used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). If patients have had pancreatitis in the past, it is not known if they have a higher chance of getting pancreatitis while taking linagliptin. Linagliptin is a DPP-4 inhibitor that does not require dose adjustment, regardless of declining renal function or hepatic impairment.

What are TRADJENTA tablets?TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

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