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).
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.
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).
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
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
change from baseline (all p<0.0001). The percentage of people who experienced hypoglycemia was not increased with greater reductions in HbA
in either group. In all four-week intervals, the percentage of people who experienced a hypoglycemic event was lower with linagliptin versus glimepiride.
About the Studies
Findings from the first exploratory analysis of data on elderly people with T2D (n=247; mean age, 74 years; baseline HbA
, 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.
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.
The study showed comparable reductions in HbA
between the two treatments.
For the exploratory analysis, the risk of investigator-reported hypoglycemia for linagliptin was compared with glimepiride based on dose, over time, and by HbA
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.
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).