1/1
2 files

Efficacy and Safety of Liraglutide versus Placebo as Add-on to Glucose Lowering Therapy in Patients with Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial

Download all (1.8 MB)
journal contribution
posted on 15.10.2015, 13:21 by Melanie J. Davies, S. C. Bain, S. L. Atkin, P. Rossing, D. Scott, M. S. Shamkhalova, H. Bosch-Traberg, A. Syren, G. E. Umpierrez
OBJECTIVE Renal impairment in type 2 diabetes limits available glucose-lowering treatment options. This trial was conducted to establish the efficacy and safety of liraglutide as an add-on to existing glucose-lowering medications in patients with inadequately controlled type 2 diabetes and moderate renal impairment. RESEARCH DESIGN AND METHODS In this 26-week, double-blind trial, 279 patients with HbA1c 7–10%, BMI 20–45 kg/m2, and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30–59 mL/min/1.73 m2; MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139). RESULTS The estimated treatment difference in HbA1c from baseline to week 26 was −0.66% (−7.25 mmol/mol) (95% CI −0.90 to −0.43 [−9.82 to −4.69]), P < 0.0001). Fasting plasma glucose decreased more with liraglutide (−1.22 mmol/L [−22.0 mg/dL]) than with placebo (−0.57 mmol/L [−10.3 mg/dL], P = 0.036). There was a greater reduction in body weight with liraglutide (−2.41 kg) than with placebo (−1.09 kg, P = 0.0052). No changes in renal function were observed (eGFR relative ratio to baseline: −1% liraglutide, +1% placebo; estimated treatment ratio [ETR] 0.98, P = 0.36). The most common adverse events were gastrointestinal (GI) adverse effects (liraglutide, 35.7%; placebo, 17.5%). No difference in hypoglycemic episodes was observed between treatment groups (event rate/100 patient-years of exposure: liraglutide, 30.47; placebo, 40.08; P = 0.54). The estimated ratio to baseline for lipase was 1.33 for liraglutide and 0.97 for placebo (ETR 1.37, P < 0.0001). CONCLUSIONS Liraglutide did not affect renal function and demonstrated better glycemic control, with no increase in hypoglycemia risk but with higher withdrawals due to GI adverse events than placebo in patients with type 2 diabetes and moderate renal impairment.

History

Citation

Diabetes Care, 2016, 39(2), 222-230

Author affiliation

/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Cardiovascular Sciences

Version

AM (Accepted Manuscript)

Published in

Diabetes Care

Publisher

American Diabetes Association

issn

0149-5992

eissn

1935-5548

Copyright date

2016

Available date

15/10/2015

Publisher version

http://care.diabetesjournals.org/content/39/2/222.short

Notes

Deposited on acceptance in accordance with the Publisher's policy, available at http://diabetes.diabetesjournals.org/site/misc/ifora.xhtml#Section8

Language

en

Usage metrics

Categories

Keywords

Exports