Date: 2011-12-08
Type of information:
phase: 3
Announcement: results
Company: Boehringer Ingelheim (Germany) Eli Lilly (USA)
Product: linagliptin (Tradjenta® in the US and Trajenta® in Europe)
Action mechanism:
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: Boehringer Ingelheim and Eli Lilly have announced results of a 24-week open label arm of a phase III study for linagliptin in initial combination with metformin, which showed meaningful reductions in blood glucose for adults with type 2 diabetes. 1 Results were presented at the International Diabetes Federation (IDF) World Diabetes Congress in Dubai. The aim of this 24-week study was to assess the safety and efficacy of linagliptin plus metformin as initial combination therapy in adult type 2 diabetes patients with poor glycaemic status. As many patients with type 2 diabetes do not reach recommended glycaemic control targets due to the current treatment protocol of first undertaking lifestyle interventions then starting monotherapy, an earlier combination therapy may be more appropriate. Initial combination therapy of linagliptin with metformin resulted in mean HbA1c reductions of –3.7% in poorly controlled patients after 24 weeks. Treatment was well tolerated with 9% of patients experiencing drug-related adverse events (AE) and only 1.5% of patients reporting hypoglycaemia. Furthermore, linagliptin demonstrated durable improvements in glycaemic control with a low risk of adverse events in a 34-week extension phase of a one year monotherapy trial. Linagliptin was compared with glimepiride in type 2 diabetes patients for whom metformin was inappropriate due to intolerance or contraindication. HbA1c levels in patients treated with linagliptin remained stable from 7.5% at week 18 to 7.4% at week 52. 2 Similar stable efficacy was observed with glimepiride when patients were switched from placebo following completion of the previous 18-week arm of the trial. Drug-related adverse events were lower with linagliptin (4.4%) compared with glimepiride (7.8%). Hypoglycaemia occurred three times less with linagliptin (2.2%) than with glimepiride (7.8%) (statistically significant); no severe episodes occurred in either group. Body weight remained stable in the linagliptin arm whereas it increased in the glimepiride arm from 82.5 kg to 85.0 kg (statistically significant) Linagliptin (trade name Tradjenta® in the US and Trajenta® in Europe and other global markets) is the only diabetes treatment to be approved at one dosage strength (5 mg, once daily) for all adult patients with type 2 diabetes without any need for dose adjustment. 4, 5 Unlike other DPP-4 inhibitors, linagliptin is primarily excreted unmetabolised via bile and gut, meaning no dose adjustment is needed in patients with declining kidney or liver function. 4, 5
