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27-03-2012 | Urology | Article

Initial linagliptin plus metformin combination effective at treating diabetes


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MedWire News: Combination linagliptin and metformin therapy is an effective and well-tolerated first-line therapy for the treatment of Type 2 diabetes, shows a study published in Diabetes, Obesity and Metabolism.

The combination therapy was superior to metformin monotherapy at reducing blood glucose levels in patients with poor glycemic control, with the additional benefits of no weight gain and a low risk for hypoglycemia, write Thomas Haak (Diabetes Center Mergentheim, Germany) and colleagues.

The findings come from a 24-week study including 687 Type 2 diabetes patients with inadequate glycemic control (glycated hemoglobin [HbA1c] ≥7.0 to <11.0%) who were either treatment naïve or had been treated with an antidiabetic drug.

After a 4-week drug washout period and a 2-week placebo run-in period, the patients were randomly allocated to receive either linagliptin 2.5 mg twice daily plus either metformin 500 mg or 1000 mg twice daily, or to receive one of the four following monotherapies: placebo, linagliptin 5 mg once daily, metformin 500 mg (low dose) twice daily, or metformin 1000 mg (high dose) twice daily.

The patients were followed up for mean change from baseline HbA1c at week 24 and safety and tolerability data were also collected throughout the study.

The researchers report that after 24 weeks of treatment, patients receiving linagliptin plus metformin showed statistically significant reductions in HbA1c from baseline compared with those on metformin or linagliptin alone.

The placebo-corrected mean reductions in HbA1c were 1.7% for linagliptin plus metformin 1000 mg, 1.3% for linagliptin plus metformin 500 mg, 1.2% for metformin 1000 mg, 0.8% for metformin 500 mg, and 0.6% for linagliptin 5 mg monotherapy.

Of note, say the authors, is the fact that the efficacy of linagliptin plus low-dose (500 mg) metformin was similar to that of high dose (1000 mg) metformin monotherapy.

The team also found that the proportion of patients reporting adverse events (AEs) and serious AEs were comparable across the active treatment groups, with most AEs being of mild or moderate intensity, indicating that combination linagliptin plus metformin therapy was generally well tolerated.

In addition, hypoglycemia occurred at low frequency and at a similar rate with linagliptin plus metformin as with metformin alone.

"We have shown that initial combination treatment with linagliptin plus metformin produced a more rapid improvement in glycemic status than the stepwise approach represented by metformin monotherapy," conclude Haak et al.

MedWire ( is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012

By Sally Robertson

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