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Vlado Perkovic, MBBS, PhD, FASN, FRACP – Professor, The George Institute for Global Health, UNSW Sydney

Bernard Zinman, MD – Senior Scientist, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada, Division of Endocrinology, University of Toronto, Toronto, Canada.

Mark E. Cooper, MD – Professor, Diabetes department at the Central Clinical School at Monash University.

Julio Rosenstock, MD – Director, Dallas Diabetes Research Center at Medical City, Dallas, TX, USA.

Steven E. Kahn, MB, ChB – Professor of Medicine, Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA.

Nikolaus Marx, MD – Professor of Medicine / Cardiology; Head of the Department of Internal Medicine I, RWTH Aachen University

Robert D. Toto, MD – Professor and associate dean, UT Southwestern’s Department of Internal Medicine

Jyothis T. George, MD, PhD – Global late stage clinical development head, Boehringer Ingelheim

John H Alexander, MD, MHS – Professor of Medicine / Cardiology, Duke Clinical Research Institute

Odd Erik Johansen, MD, PhD – Global Clinical Program Lead, Boehringer Ingelheim


Objective :

Type 2 diabetes (T2D) is a common cause of end-stage kidney disease and is associated with CV complications.Dipeptidyl peptidase-4 inhibitors (DPP-4i) have been studied in several dedicated CV outcome trials, but the number of participants with chronic kidney disease (CKD) has been limited; hence there is a dearth of clinical outcomes data in this population.

Methods :

CARMELINA® (NCT01897532) randomized people with T2D and either i) UACR >30 mg/g with concomitant CV disease, or ii) eGFR 200 mg/g, to receive the DPP-4i linagliptin (5 mg) or placebo once daily in a double-blind fashion. The primary CV endpoint was 3P-MACE, with a key secondary kidney endpoint adjudicated ESKD, renal death, or sustained ≥40% decrease in eGFR from baseline. Glycemic effects and hypoglycemia were also analyzed. Subgroups were assessed by baseline kidney function (eGFR ≥/<45).

Results :

6979 participants (mean age 65.9 years, HbA1c 8.0%, eGFR 54.6 ml/min/1.73m2, 43% eGFR 30 mg/g) from 605 centers across 27 countries were followed-up for median 2.2 yrs. Linagliptin reduced HbA1c (overall mean (95% CI) difference linagliptin vs placebo -0.36% (-0.42, -0.29) based on least square means), regardless of eGFR  (eGFR < 45: -0.35% (-0.45, -0.25); eGFR ≥ 45: -0.36% (-0.45, -0.28)), with fewer patients initiating or intensifying insulin in the linagliptin group (HR 0.75 (0.65, 0.81), also regardless of eGFR (eGFR < 45: HR 0.69 (0.59, 0.81); eGFR ≥ 45: HR 0.76 (0.65, 0.88)). Risk for 3P-MACE (HR 1.02 (0.89, 1.17), hospitalization for heart failure (hHF) (HR 0.90 (0.74, 1.08), the secondary kidney endpoint (HR 1.04 (0.89, 1.22)), were also similar between randomized groups. All outcomes occurred at higher incidence rates in those with reduced eGFR, however, results were consistent across eGFR subgroups (p heterogeneity >0.1). Incidence rates of any hypoglycaemia (100 participant-yrs) was not different across treatment groups (linagliptin: 19.9, placebo 20.2), including in those with eGFR < 45 (linagliptin: 28.4, placebo: 28.5) or eGFR ≥ 45 (linagliptin 14.5, placebo 14.9).

Discussion :

The use of linagliptin over a median 2.2 years compared with placebo resulted in a noninferior risk of a composite CV outcome with no effect on the secondary kidney outcome or hHF. HbA1c was significantly reduced with linagliptin regardless of eGFR, without increasing risk for hypoglycaemia.

Conclusion :

In a large, international CV outcome trial in participants with T2D and concomitant CV and/or kidney disease, linagliptin did not affect CV/hHF/kidney risk. Significant reductions in HbA1c and insulin need was observed regardless of eGFR.  

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