Lilly, Boehringer Ingelheim announce results from linagliptin Phase III trial on T2D

Jun 11 2012

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) presented results from a randomised Phase III clinical trial and a post-hoc analysis for linagliptin at ADA. The results showed that adults with type 2 diabetes (T2D) treated with linagliptin in combination with certain other diabetes therapies achieved clinically meaningful blood glucose control. Linagliptin is a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D.

"Type 2 diabetes is a chronic, progressive condition and glycaemic control becomes harder to achieve over the long term," said Professor Baptist Gallwitz, Eberhard-Karls-University, Germany. "Metformin is a standard first-line treatment and many patients eventually require insulin to maintain glycaemic targets. Taken together, these two studies show that linagliptin can provide meaningful glycaemic control both in the early and later stages of the disease. In addition linagliptin is the only diabetes treatment to be approved at one dosage strength meaning physicians can be confident their patients are always on the right dose."

Results of the one Phase III study presented (Poster No. 999-P) showed that linagliptin was effective as an add-on therapy to basal insulin alone or in combination with metformin and/or pioglitazone in reducing blood glucose levels in adult patients with T2D, when compared to placebo as an add-on to these background therapies. Linagliptin demonstrated a placebo-adjusted reduction in HbA1c of 0.65% (p<0.0001) from a baseline HbA1c of 8.3% at 24 weeks without weight gain or additional risk of hypoglycaemia.¹ HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.

A post-hoc analysis from a second Phase III trial (Poster No. 1044-P) found that in hyperglycaemic patients on a background of metformin randomised to add linagliptin or glimepiride, a greater proportion of patients taking linagliptin achieved target HbA1c <7% without weight gain and/or hypoglycaemia than those taking glimepiride after 104 weeks (linagliptin 54% versus glimepiride 23%) while comparably improving blood glucose levels.