It is licensed for use when metformin alone is inadequate; in patients who are currently receiving the combination as separate tablets; or with a sulfonylurea when a sulfonylurea plus metformin is inadequate.
Jentadueto provides a fixed dose of two antidiabetic agents with complementary mechanisms of action: linagliptin, a dipeptidyl peptidase 4 inhibitor and metformin, a member of the biguanide class.1
A randomised, double-blind 24-week phase III study assessed the efficacy and safety of linagliptin plus metformin in 791 patients with type II diabetes. Patients received either a combination of linagliptin and metformin, metformin alone, linagliptin alone or placebo. Linagliptin was given at 2.5mg twice daily in combination treatment and at 5mg once daily in monotherapy. Metformin was given at either 500mg or 1g twice daily for both combination treatment and monotherapy.2
At maximum dose (linagliptin 2.5mg/metformin 1g twice daily), the combination provided a placebo-corrected mean reduction in glycosylated haemoglobin (HbA1c), the primary endpoint, of up to –1.7% (95% CI –2.0 to –1.4, p<0.0001). Corresponding reductions were –1.3% for linagliptin 2.5mg/metformin 500mg, –1.2% for metformin 1g, 0.8% for metformin 500mg and –0.6% for linagliptin. Both doses of the combination were superior to metformin or linagliptin monotherapy (p<0.0001 for all comparisons).2
The most frequently reported adverse reactions with linagliptin plus metformin were diarrhoea and nasopharyngitis. Rates of hypoglycaemia for the combination (1.7%) were similar to those for metformin alone (2.4%).2
1. Jentadueto Summary of Product Characteristics, July 2012.
2. Haak T et al. Diabetes Obes Metab 2012; 14: 565-74.
View Jentadueto drug record
Further information: Boehringer Ingelheim
Follow MIMS on Twitter