Phase IIIb study begins evaluating Trajenta in Type II diabetes patients with albuminuria
Boehringer Ingelheim and Eli Lilly have reported the initiation of a Phase IIIb trial, MARLINA, to evaluate the glycaemic efficacy and safety of Trajenta (linagliptin) in Type II diabetes patients with prevalent albuminuria, and urinary albumin-to-creatinine ratio 30 to 3,000mg/g creatinine, in addition to current standard therapy for diabetic nephropathy.
MARLINA is a multi-centre, multi-national, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the glycaemic efficacy of once daily administration of linagliptin (5mg for 24 weeks) in Type II diabetes patients, with micro- or macroalbuminuria (30 to 3,000mg/g creatinine) in addition to current standard treatment for diabetic nephropathy (ACE inhibitor or angiotensin receptor blocker). The primary endpoint is the change from baseline in HbA1c after 24 weeks of treatment. The study is expected to complete in 2014.
The FDA, EMA and other regulatory authorities worldwide have approved Trajenta for the treatment of adults with Type II diabetes as monotherapy or in combination with metformin, metformin plus sulphonylurea, and as add-on therapy to insulin. In the US, Trajenta is also approved for use in this population with sulphonylurea and with pioglitazone. With Trajenta, no dose adjustment is required regardless of declining renal function or hepatic impairment.