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

Affiliations

¹ Diabetes and Lifestyle Center, Tomonaga Clinic, Shinyon Curumu Building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan.
² Department of Medicine, Tokyo Women's Medical University, Medical Center East, 2-1-10, Nishiogu, Arakawa-ku, Tokyo 116-8567, Japan.
³ Department of Diabetes, Endocrine and Metabolic Diseases, Tokyo Women's Medical University Yachiyo Medical Center, 477-96, Owadashinden, Yachiyo-shi, Chiba 276-0046, Japan.
⁴ Internal Medicine, Suzuki Clinic, 2-10-14, Koyasu-machi, Hachioji-shi, Tokyo 192-0904, Japan.
⁵ Internal Medicine, Oyama East Clinic, 1-32-1, Ekihigashi-dori, Oyama-shi, Tochigi 323-0022, Japan.
⁶ Internal Medicine, Nishiyamado-Keiwa Hospital, 3247-1, Kounosu, Naka-shi, Ibaraki 311-0133, Japan.
⁷ Department of Medicine, Diabetes Center, Institute of Geriatrics, Tokyo Women's Medical University, Shibuya Cross Tower 22F, 2-15-1, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan.
⁸ Josai Hospital, 2-42-11, Kamiogi, Suginami-ku, Tokyo 167-0043, Japan.
⁹ Diabetes Center, Edogawa Hospital, Medical Plaza Shinozaki, SK Building, Shinozakimachi, Edogawa-ku, Tokyo 133-0057, Japan.
¹⁰ Nishikawa Clinic, 2-16-3, Towa, Adachi-ku, Tokyo 120-0003, Japan.
¹¹ The Institute for Adult Diseases, Asahi Life Foundation, Asahiseimeisunaga Building, 2-2-6, Nihonbashi Bakuro-cho, Chuo-ku, Tokyo 103-0002, Japan.

PMID: 29238432
PMCID: PMC5722043
DOI: 10.14740/jocmr3225w

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.

. 2018 Jan;10(1):32-40.

doi: 10.14740/jocmr3225w. Epub 2017 Dec 1.

Authors

Affiliations

¹ Diabetes and Lifestyle Center, Tomonaga Clinic, Shinyon Curumu Building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan.
² Department of Medicine, Tokyo Women's Medical University, Medical Center East, 2-1-10, Nishiogu, Arakawa-ku, Tokyo 116-8567, Japan.
³ Department of Diabetes, Endocrine and Metabolic Diseases, Tokyo Women's Medical University Yachiyo Medical Center, 477-96, Owadashinden, Yachiyo-shi, Chiba 276-0046, Japan.
⁴ Internal Medicine, Suzuki Clinic, 2-10-14, Koyasu-machi, Hachioji-shi, Tokyo 192-0904, Japan.
⁵ Internal Medicine, Oyama East Clinic, 1-32-1, Ekihigashi-dori, Oyama-shi, Tochigi 323-0022, Japan.
⁶ Internal Medicine, Nishiyamado-Keiwa Hospital, 3247-1, Kounosu, Naka-shi, Ibaraki 311-0133, Japan.
⁷ Department of Medicine, Diabetes Center, Institute of Geriatrics, Tokyo Women's Medical University, Shibuya Cross Tower 22F, 2-15-1, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan.
⁸ Josai Hospital, 2-42-11, Kamiogi, Suginami-ku, Tokyo 167-0043, Japan.
⁹ Diabetes Center, Edogawa Hospital, Medical Plaza Shinozaki, SK Building, Shinozakimachi, Edogawa-ku, Tokyo 133-0057, Japan.
¹⁰ Nishikawa Clinic, 2-16-3, Towa, Adachi-ku, Tokyo 120-0003, Japan.
¹¹ The Institute for Adult Diseases, Asahi Life Foundation, Asahiseimeisunaga Building, 2-2-6, Nihonbashi Bakuro-cho, Chuo-ku, Tokyo 103-0002, Japan.

PMID: 29238432
PMCID: PMC5722043
DOI: 10.14740/jocmr3225w

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**
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**
Participant flow in the study.

**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**
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**
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.

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References

1. Drucker DJ. Enhancing incretin action for the treatment of type 2 diabetes. Diabetes Care. 2003;26(10):2929–2940. doi: 10.2337/diacare.26.10.2929. - DOI - PubMed
1. Herman GA, Bergman A, Stevens C, Kotey P, Yi B, Zhao P, Dietrich B. et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab. 2006;91(11):4612–4619. doi: 10.1210/jc.2006-1009. - DOI - PubMed
1. Iwamoto Y, Taniguchi T, Nonaka K, Okamoto T, Okuyama K, Arjona Ferreira JC, Amatruda J. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383–394. doi: 10.1507/endocrj.K09E-272. - DOI - PubMed
1. Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC. et al. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011;2(5):381–390. doi: 10.1111/j.2040-1124.2011.00120.x. - DOI - PMC - PubMed
1. Kadowaki T, Tajima N, Odawara M, Nishii M, Taniguchi T, Ferreira JC. Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks. J Diabetes Investig. 2013;4(2):174–181. doi: 10.1111/jdi.12001. - DOI - PMC - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

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