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. 2016 Jul 19;4(1):e000265.
doi: 10.1136/bmjdrc-2016-000265. eCollection 2016.

Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

Katsuhito Mori  1 , Masanori Emoto  1 , Tetsuo Shoji  2 , Masaaki Inaba  1
Affiliations

Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

Katsuhito Mori et al. BMJ Open Diabetes Res Care. .

Abstract

Objective: Focusing on efficacy and tolerability, we compared linagliptin monotherapy with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis (HD).

Research design and methods: In this multicenter, randomized, open-label, parallel-group, active-controlled study, 78 patients were randomized (1:1) to receive a 12-week treatment with 5 mg linagliptin once daily or 0.2 mg voglibose three times a day. To assess whether linagliptin was superior to voglibose, the primary efficacy end point was the change in glycated hemoglobin (HbA1c) level between baseline and week 12. Secondary efficacy end points included changes between baseline and week 12 in glycated albumin (GA) and casual plasma glucose (PG) levels.

Results: At week 12, the adjusted mean HbA1c levels had decreased by -0.60% after treatment with linagliptin and by -0.20% after treatment with voglibose (treatment difference: -0.40%, 95% CI -0.74% to -0.06%, p=0.022). A significant reduction in casual PG level was also observed after treatment with linagliptin compared with treatment with voglibose. Relative to voglibose, linagliptin tended to elicit reductions in GA, although without statistical significance. No hypoglycemic symptoms or severe hypoglycemia occurred during the study.

Conclusions: In patients with type 2 diabetes undergoing HD, linagliptin monotherapy provided significantly better glycemic control without severe hypoglycemia than voglibose monotherapy. Linagliptin represents a promising agent for glycemic management in patients with type 2 diabetes undergoing HD.

Trial registration number: UMIN000007635; results.

Keywords: A1C; Nephropathy; Oral Antidiabetics.

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Figures

Figure 1
Figure 1
Study flow diagram. FAS, full analysis set.
Figure 2
Figure 2
(A) Time course of changes in glycated hemoglobin (HbA1c) (mean±SEM). (B) Changes from baseline to week 12 in adjusted HbA1c (mean±SEM) in the full analysis set (last observation carried forward).
See this image and copyright information in PMC

References

    1. Desouza CV, Bolli GB, Fonseca V. Hypoglycemia, diabetes, and cardiovascular events. Diabetes Care 2010;33:1389–94. - PMC - PubMed
    1. Ricks J, Molnar MZ, Kovesdy CP et al. . Glycemic control and cardiovascular mortality in hemodialysis patients with diabetes: a 6-year cohort study. Diabetes 2012;61:708–15. - PMC - PubMed
    1. Ramirez SP, McCullough KP, Thumma JR et al. . Hemoglobin A(1c) levels and mortality in the diabetic hemodialysis population: findings from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Diabetes Care 2012;35:2527–32. - PMC - PubMed
    1. Shurraw S, Hemmelgarn B, Lin M et al. , Alberta Kidney Disease Network. Association between glycemic control and adverse outcomes in people with diabetes mellitus and chronic kidney disease: a population-based cohort study. Arch Intern Med 2011;171:1920–7. - PubMed
    1. Morioka T, Emoto M, Tabata T et al. . Glycemic control is a predictor of survival for diabetic patients on hemodialysis. Diabetes Care 2001;24:909–13. - PubMed

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