Date: 2013-03-19
Type of information:
phase: 3b
Announcement:
Company: Boehringer Ingelheim (Germany) Eli Lilly (USA)
Product: linagliptin (Tradjenta® in the US and Trajenta® in Europe)
Action mechanism:
Disease: patients with type 2 diabetes with prevalent albuminuria
Therapeutic area: Metabolic diseases
Country: USA, Canada, Denmark, Finland, France, Germany, Japan, Republic of Korea, Spain, Taiwan
Trial details: MARLINA (efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin) is a 24-week, Phase IIIb, multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the glycemic efficacy of once-daily administration of linagliptin 5 mg in patients with type 2 diabetes with micro- or macroalbuminuria (30-3000mg/g creatinine) in addition to current standard treatment for diabetic nephropathy angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker. (NCT01792518)
Latest
news: * On March 19, 2013, Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced the initiation of a Phase IIIb trial to evaluate the glycemic efficacy and safety of linagliptin in patients with type 2 diabetes with prevalent albuminuria (defined as urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g creatinine), while remaining on current standard therapy for diabetic nephropathy.
The primary endpoint of MARLINA is the change from baseline in HbA1c after 24 weeks of treatment. The study is expected to be completed in 2014.
