Boehringer Ingelheim and Eli Lilly and Company have announced results from a post-hoc analysis that showed Linagliptin ( U.S. as Tradjenta, in Europe as Trajenta ) is associated with improvements in glucose levels and a significant reduction in urinary albumin-to-creatinine ratio ( UACR ) of 33% (p less than 0.05 ) from baseline in patients with type 2 diabetes mellitus and at high risk of declining renal function ( some degree of albuminuria at baseline ).

Linagliptin is a once-daily tablet that is used along with diet and exercise either as monotherapy or in combination with other treatments, such as Metformin or Metformin plus sulphonylurea, to improve glycaemic control in adults with type 2 diabetes mellitus.

In a post-hoc analysis, data from four randomised, double-blind, 24-week, placebo-controlled trials of Linagliptin monotherapy, Linagliptin with add-on to Metformin, Linagliptin with add-on to Metformin and sulphonylurea and a factorial study of Linagliptin in initial combination with Metformin were pooled ( n=2472 ) to explore the clinical effect of Linagliptin on albuminuria in patients with type 2 diabetes mellitus who are at high risk of declining renal function ( including albuminuria at baseline ).

UACR was collected in the four trials as safety data. The endpoint was the percentage change in geometric mean UACR. In this analysis, 492 ( 19.9% ) patients met UACR ( 30 less than or equal to UACR less than or equal 3000 mg/g creatinine ) and estimated glomerular filtration rate ( eGFR ) thresholds ( eGFR greater than 30 ml/ min/1.73m2 ) of whom 46% received stable angiotensin-converting enzyme inhibitor ( ACE ) or angiotensin receptor blocker ( ARB ) therapy ( Linagliptin n=168; placebo n=59 ).

Mean baseline haemoglobin A1c [HbA1c] and median UACR were 8.2% versus 8.5% and 76 versus 78 mg/g creatinine for the Linagliptin and placebo groups, respectively.

After 24 weeks, placebo-corrected changes in HbA1c and FPG were -0.71% and -26 mg/dL respectively ( both p less than 0.0001 ). Linagliptin significantly lowered UACR by 33% compared to baseline ( p less than 0.05 ) with a between-group difference of -29% ( p less than 0.05 ).

Source: Boehringer Ingelheim, 2012

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