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Aims  The  MARLINA ‐ T2D  study ( ClinicalTrials.gov ,  NCT 01792518) was designed to investigate the glycaemic and renal effects of linagliptin added to standard‐of‐care in individuals with type 2 diabetes and albuminuria.    Methods  A total of 360 individuals with type 2 diabetes,  HbA1c  6.5% to 10.0% (48–86 mmol/mol), estimated glomerular filtration rate ( eGFR ) ≥30 mL/min/1.73 m 2  and urinary albumin‐to‐creatinine ratio ( UACR ) 30–3000 mg/g despite single agent renin‐angiotensin‐system blockade were randomized to double‐blind linagliptin ( n  = 182) or placebo ( n  = 178) for 24 weeks. The primary and key secondary endpoints were change from baseline in  HbA1c  at week 24 and time‐weighted average of percentage change from baseline in  UACR  over 24 weeks, respectively.    Results  Baseline mean  HbA1c  and geometric mean ( gMean )  UACR  were 7.8% ± 0.9% (62.2 ± 9.6 mmol/mol) and 126 mg/g, respectively; 73.7% and 20.3% of participants had microalbuminuria or macroalbuminuria, respectively. After 24 weeks, the placebo‐adjusted mean change in  HbA1c  from baseline was −0.60% (−6.6 mmol/mol) (95% confidence interval [ CI ], −0.78 to −0.43 [−8.5 to −4.7 mmol/mol];   P   < .0001). The placebo‐adjusted  gMean  for time‐weighted average of percentage change in  UACR  from baseline was −6.0% (95%  CI , −15.0 to 3.0;   P   = .1954). The adverse‐event profile, including renal safety and change in  eGFR , was similar between the linagliptin and placebo groups.    Conclusions  In individuals at early stages of diabetic kidney disease, linagliptin significantly improved glycaemic control but did not significantly lower albuminuria. There was no significant change in placebo‐adjusted  eGFR . Detection of clinically relevant renal effects of linagliptin may require longer treatment, as its main experimental effects in animal studies have been to reduce interstitial fibrosis rather than alter glomerular haemodynamics.

diabetes, obesity and metabolism

Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized  MARLINA ‐ T2D  trial