Eli Lilly and Boehringer Ingelheim presented results from two randomized phase 3 clinical trials and a post-hoc analysis for linagliptin, marketed under the name Tradjenta in the U.S, at the American Diabetes Association’s (ADA) 72nd Scientific Sessions. The new studies provide additional data evaluating the efficacy and safety of Tradjenta (linagliptin) (alone or in combination with other diabetes therapies) in adults with type 2 diabetes.
The first data presented was the interim results of the first phase 3 52-week, multicenter, randomized, placebo-controlled study which evaluated the efficacy and safety of linagliptin as an add-on therapy to basal insulin alone, or in combination with metformin and/or pioglitazone in adult patients with type 2 diabetes. The study included 1,261 patients who had inadequate glycemic control with a stable dose of basal insulin with or without metformin and/or pioglitazone (i.e., insulin glargine, insulin detemir or NPH insulin). Patients were randomized to receive either 5 mg of linagliptin or placebo once daily. The primary efficacy endpoint was the mean change in A1c from baseline to week 24, during which time the basal insulin and metformin and /or pioglitazone dose remained stable.
The second study presented was a randomized, placebo-controlled, double-blind phase 3 study which evaluated the efficacy and safety of linagliptin 5 mg daily in 241 elderly patients (74.9 years +4.3 years) with type 2 diabetes, who had insufficient glycemic control despite treatment with metformin, sulfonylurea and/or insulin therapy. Patients were randomized to receive either 5 mg of linagliptin once daily, or placebo as an add-on to stable background therapy over 24 weeks. Patients were taking either metformin (84.9 percent), sulfonylurea (57.6 percent) or insulin therapy (21.0 percent). Baseline A1c was 7.8 percent and 7.7 percent in the linagliptin and placebo groups, respectively. Drug-related adverse events were experienced by 21.0 percent and 13.9 percent of linagliptin and placebo patients, respectively. Hypoglycemia occurred in 24.1 percent and 16.5 percent, respectively.
The third study was an exploratory analysis of a 104-week study assessed the proportions of adult patients with type 2 diabetes treated with linagliptin versus glimepiride both on a background of metformin who achieved a glycemic target of A1c < 7 percent without weight gain and without hypoglycemia (defined event per protocol). A total of 504 patients were evaluable (233 linagliptin; 271 glimepiride). Baseline A1c levels were similar in the two groups (linagliptin, 7.2 percent and glimepiride, 7.3 percent). Six percent of linagliptin patients experienced hypoglycemia versus 22 percent on glimepiride and 22 percent experienced weight gain, versus 55 percent on glimepiride. Consequently, a significantly higher proportion in the linagliptin group than with the glimepiride group achieved the composite endpoint (54 percent versus 23 percent, respectively).
Tradjenta is a once-daily tablet that is used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).