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. 2018 Jan;10(1):32-40.
doi: 10.14740/jocmr3225w. Epub 2017 Dec 1.

Renal Function During an Open-Label Prospective Observational Trial of Sitagliptin in Patients With Diabetes: A Sub-Analysis of the JAMP Study

Osamu Tomonaga  1 , Hiroshi Sakura  2 , Naotake Hashimoto  3 , Kazuo Sasamoto  4 , Hiroshi Ohashi  5 , Sumiko Hasumi  6 , Noriko Ujihara  7 , Tadasu Kasahara  8 , Hideo Nunome  9 , Masashi Honda  10 , Yasuhiko Iwamoto  11 ; JAMP Study Investigators
Affiliations

Renal Function During an Open-Label Prospective Observational Trial of Sitagliptin in Patients With Diabetes: A Sub-Analysis of the JAMP Study

Osamu Tomonaga et al. J Clin Med Res. 2018 Jan.

Abstract

Background: The aim of the study was to determine the effects of sitagliptin on renal function in a diabetic population including patients with normal renal function.

Methods: We analyzed the association between 12-month, 50 mg/day sitagliptin and renal function in outpatients with type 2 diabetes mellitus and poor blood glucose control in a subset of patients in the larger Januvia Multicenter Prospective Trial in Type 2 Diabetes observational study. Stratified analyses of changes in estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR) were performed. Factors associated with changes in eGFR at 3 months were examined by multivariate regression analysis.

Results: Of the 779 patients enrolled, 585 were followed up for 12 months. eGFR decreased significantly from baseline at 3 and 12 months in patients with a baseline eGFR of ≥ 90 mL/min/1.73 m2 and in those with a baseline eGFR of ≥ 60 to < 90 mL/min/1.73 m2. Conversely, eGFR tended to increase at 3 and 12 months in patients with a baseline eGFR of ≥ 45 to < 60 mL/min/1.73 m2 and in those with a baseline eGFR of ≥ 30 to < 45 mL/min/1.73 m2. UACR decreased significantly (-21.6 (-46.8, 7.8)) at 3 months in patients with a baseline UACR of ≥ 30 mg/g Cre. Multivariate regression analysis of factors associated with changes in eGFR at 3 months revealed that higher baseline eGFR and greater decline in UACR were associated with more conspicuous decreases in eGFR.

Conclusions: In this group of diabetic patients receiving sitagliptin, eGFR declined in patients with high baseline eGFR, but not in those with a low baseline eGFR.

Keywords: DPP-4 inhibitor; JAMP; Prospective observational study; Renal function; Sitagliptin.

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Conflict of interest statement

Hiroshi Sakura received honoraria from Mitsubishi Tanabe Pharma Corporation and research grant from Ono Pharmaceutical Co., Ltd. Other authors declare that they have no conflict of interest.

Figures

Figure 1
Figure 1
Study design. *1: criteria for inadequate blood glucose control: HbA1c level ≥ 6.9% or fasting blood glucose level ≥ 130 mg/dL. *2: specific investigational tests (optional): GA, 1.5AG, C-peptide, and proinsulin-to-insulin ratio.
Figure 2
Figure 2
Participant flow in the study.
Figure 3
Figure 3
Changes in eGFR (categorized by baseline eGFR). (a) *P < 0.05 vs. 0 M paired t-test. (b) Values presented are mean ± SD.
Figure 4
Figure 4
Changes in HbA1c (categorized by baseline eGFR). (a) eGFR: estimated glomerular filtration rate. *P < 0.05 vs. baseline, paired t-test. (b) Values presented are mean ± SD. N.S. ANOVA.
Figure 5
Figure 5
Change in UACR of patients (n = 53) with a baseline UACR ≥ 30 mg/g Cre. Data are first, second, third quartile. Change at: 3 months: -21.6 (-46.8, 7.8); 12 months: -17.1 (-39.8, 23.8). †P < 0.05 vs. baseline, Wilcoxon signed rank test.
See this image and copyright information in PMC

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