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

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2017-11, Vol.19 (11), p.1610-1619
• Main Authors: Groop, Per‐Henrik, Cooper, Mark E., Perkovic, Vlado, Hocher, Berthold, Kanasaki, Keizo, Haneda, Masakazu, Schernthaner, Guntram, Sharma, Kumar, Stanton, Robert C., Toto, Robert, Cescutti, Jessica, Gordat, Maud, Meinicke, Thomas, Koitka‐Weber, Audrey, Thiemann, Sandra, von Eynatten, Maximilian
• Format: Article
• Language: English
• Subjects: Aged; Albuminuria - drug therapy; Albuminuria - etiology; antidiabetic drug; Blood Glucose - drug effects; Blood Glucose - metabolism; clinical trial; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetic Nephropathies - blood; Diabetic Nephropathies - drug therapy; diabetic nephropathy; Double-Blind Method; DPP‐IV inhibitor; Evidence-based medicine; Female; glycaemic control; Humans; Hyperglycemia; Hyperglycemia - chemically induced; Kidney diseases; linagliptin; Linagliptin - therapeutic use; Male; Middle Aged; Original; Renal Insufficiency - complications; Renal Insufficiency - drug therapy; Renal Insufficiency - epidemiology; Standard of Care; Treatment Outcome
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.13041

Aims The MARLINA‐T2D study (ClinicalTrials.gov, NCT01792518) 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 m2 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