Reduction in blood glucose with linagliptin alone and in combination with metformin in newly diagnosed Type 2 Diabetes
Data from a phase IV study show that linagliptin 5 mg as monotherapy and in combination with metformin (1500 or 2000 mg) gave clinically significant improvements in glucose control in treatment-naive adults with newly diagnosed uncontrolled type 2 diabetes (T2D). Both treatments provided statistically significant reductions in blood glucose levels, with combination therapy giving statistically significantly greater reductions than did monotherapy.
The results were presented during the 2013 World Diabetes Congress, in Melbourne, Australia.
In this international double-blind clinical trial, 316 adults with a mean plasma glucose concentration (HbA1c) of 9.8 % were randomised to receive linagliptin 5 mg once-daily (n =157) or to 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 main results were:
- Linagliptin monotherapy and linagliptin + metformin initial combination therapy demonstrated statistically significant reductions in HbA1c of 2.0 % and 2.8 %, respectively.
- A proportion of patients achieved a target HbA1c of <7 % at week 24 with linagliptin + metformin and linagliptin monotherapy (61 % and 39 %, respectively).
- Both treatments were well tolerated overall with few drug-related or serious adverse events.
- Hypoglycaemia occurred in 3.2 % and 1.9 % with linagliptin monotherapy and combination therapy, respectively.
- Body weight was stable with linagliptin and decreased in the combination arm (–1.3 kg between group difference).
Linagliptin (5 mg) is a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. No dose adjustment is required with linagliptin, except when given as a fixed dose combination with metformin, regardless of renal or hepatic function and hence, it can be used at one single dose in a broad range of patients.
Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis.
Press release Boehringer Ingelheim December 3 2013