Boehringer Ingelheim (BI) and Eli Lilly and Company announced new data1 from a phase IV study evaluating linagliptin (5 mg) as monotherapy and in combination with metformin (1500 or 2000 mg) in treatment-naive adults with newly diagnosed (<12 months) uncontrolled Type 2 Diabetes (T2D). The result showed that linagliptin as monotherapy or in initial combination with metformin achieved clinically significant improvements in glucose control in patients with newly diagnosed T2D and marked hyperglycaemia. Results also showed both treatments provided statistically significant reductions in blood glucose levels, with the combination therapy having greater glucose reduction compared to monotherapy.

Study showed significant reductions of HbA1c up to 2.8 per cent in treatment-naïve adults with uncontrolled T2D and marked hyperglycaemia (HbA1c >8.5 per cent). Linagliptin monotherapy and in combination with metformin was well tolerated with no significant adverse events. No weight gain seen with linagliptin monotherapy; average weight loss of 1.1 kg seen in combination therapy with metformin.

The study randomised 316 adults with a mean average plasma glucose concentration (HbA1c) of 9.8 per cent to receive linagliptin 5 mg once-daily (n = 157) and the initial combination of linagliptin 5 mg once-daily plus metformin twice-daily (uptitrated to a maximal dose of 2000 mg/d; n = 159) for 24 weeks. The results showed:

Linagliptin monotherapy and linagliptin + metformin initial combination therapy demonstrated statistically significant reductions in HbA1c of 2.0 per cent and 2.8 per cent, respectively. HbA1c reduction with the initial combination of linagliptin + metformin was statistically superior to linagliptin alone.

A proportion of patients achieved a target HbA1c of <7 per cent at week 24 with linagliptin + metformin and linagliptin monotherapy (61 per cent and 39 per cent, respectively).

Both treatments were well tolerated overall with few drug-related or serious adverse events.

Hypoglycaemia occurred in 3.2 per cent and 1.9 per cent with linagliptin monotherapy and linagliptin + metformin initial combination therapy, respectively.

Body weight was stable with linagliptin and decreased in the combination arm (–1.3 kg between group difference).

“Improving glycaemic control in the early stages of T2D is important, especially in adults with high glucose levels upon initial diagnosis,” said Professor Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim. “The significant drop in HbA1c seen with both linagliptin monotherapy and in initial combination with metformin highlights the importance of these treatment choices for people with T2D.”

The US FDA, EMA and several other regulatory authorities worldwide have approved linagliptin for the treatment of adults with T2D as monotherapy or in combination with metformin, metformin + sulphonylurea, and as add-on therapy to insulin. With linagliptin, except as fixed dose combination with metformin, no dose adjustment is required regardless of renal or hepatic function and hence, it can be used at one single dose in a broad range of patients.