Short-term renal and metabolic effects of low dose vildagliptin treatment added-on insulin therapy in non-proteinuric patients with type 2 diabetes: open-label randomized prospective study

ABSTRACT Objective The aim of this randomized comparative study was to assess renal and metabolic effects of vildagliptin in insulin-treated type 2 diabetes (T2DM) patients without overt chronic kidney disease. Subjects and methods We randomized 47 insulin-treated non-proteinuric patients with satis...

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Published in:Archives of Endocrinology and Metabolism 2020-08, Vol.64 (4), p.418-426
Main Authors: Bayrasheva, Valentina K., Pchelin, Ivan Y., Dobronravov, Vladimir A., Babenko, Alina Yu, Chefu, Svetlana G., Shatalov, Ivan S., Vasilkova, Volha N., Hudiakova, Natalia V., Ivanova, Alexandra N., Andoskin, Pavel A., Grineva, Elena N.
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Language:English
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cystatin C
NGAL
Original
renal function
type 2 diabetes
type IV collagen
Vildagliptin
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container_title Archives of Endocrinology and Metabolism
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creator Bayrasheva, Valentina K.
Pchelin, Ivan Y.
Dobronravov, Vladimir A.
Babenko, Alina Yu
Chefu, Svetlana G.
Shatalov, Ivan S.
Vasilkova, Volha N.
Hudiakova, Natalia V.
Ivanova, Alexandra N.
Andoskin, Pavel A.
Grineva, Elena N.
description ABSTRACT Objective The aim of this randomized comparative study was to assess renal and metabolic effects of vildagliptin in insulin-treated type 2 diabetes (T2DM) patients without overt chronic kidney disease. Subjects and methods We randomized 47 insulin-treated non-proteinuric patients with satisfactory controlled T2DM and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 either to continue insulin therapy (control) or to receive combined insulin-vildagliptin treatment (VIG group). We assessed eGFR using serum creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys), and urinary creatinine-adjusted excretion of albumin (UACR), type IV collagen (uCol IV/Cr), and neutrophil gelatinase-associated lipocalin (uNGAL/Cr) at baseline and after 6 months of treatment. Results Study groups were comparable in terms of age and sex (60.1 ± 6.1 years and 42.9% men in control group vs. 60.8 ± 5.2 years and 39.1% in VIG group). After 6 months of treatment, there were no significant changes in main assessed parameters in control group. VIG group demonstrated significant decrease in HbA1c, diastolic blood pressure, frequency of hypoglycemia, and high-sensitivity C-reactive protein level as compared to the changes in control group. While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p < 0.01 each). Correlation and regression analysis revealed glucose-independent pattern of these changes. Conclusion Addition of vildagliptin to ongoing insulin therapy in patients with T2DM was associated with a reduction in uCol IV/Cr and an increase in eGFRcys and eGFRcreat-cys, independent of T2DM control parameters.
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Subjects and methods We randomized 47 insulin-treated non-proteinuric patients with satisfactory controlled T2DM and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 either to continue insulin therapy (control) or to receive combined insulin-vildagliptin treatment (VIG group). We assessed eGFR using serum creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys), and urinary creatinine-adjusted excretion of albumin (UACR), type IV collagen (uCol IV/Cr), and neutrophil gelatinase-associated lipocalin (uNGAL/Cr) at baseline and after 6 months of treatment. Results Study groups were comparable in terms of age and sex (60.1 ± 6.1 years and 42.9% men in control group vs. 60.8 ± 5.2 years and 39.1% in VIG group). After 6 months of treatment, there were no significant changes in main assessed parameters in control group. VIG group demonstrated significant decrease in HbA1c, diastolic blood pressure, frequency of hypoglycemia, and high-sensitivity C-reactive protein level as compared to the changes in control group. While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p &lt; 0.01 each). Correlation and regression analysis revealed glucose-independent pattern of these changes. Conclusion Addition of vildagliptin to ongoing insulin therapy in patients with T2DM was associated with a reduction in uCol IV/Cr and an increase in eGFRcys and eGFRcreat-cys, independent of T2DM control parameters.</description><identifier>ISSN: 2359-3997</identifier><identifier>EISSN: 2359-4292</identifier><identifier>DOI: 10.20945/2359-3997000000220</identifier><identifier>PMID: 32267348</identifier><language>eng</language><publisher>Sociedade Brasileira de Endocrinologia e Metabologia</publisher><subject>cystatin C ; NGAL ; Original ; renal function ; type 2 diabetes ; type IV collagen ; Vildagliptin</subject><ispartof>Archives of Endocrinology and Metabolism, 2020-08, Vol.64 (4), p.418-426</ispartof><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c461t-dd39742a4d15ce8470d5e46fae4fa107d0b45ab2ab2712f4200f4b7a2df9e343</cites><orcidid>0000-0002-0559-697X ; 0000-0002-6956-9014 ; 0000-0002-1180-3365 ; 0000-0002-9249-660X ; 0000-0002-1676-5898 ; 0000-0001-8529-3890 ; 0000-0002-7034-0962 ; 0000-0003-0042-7680 ; 0000-0003-0187-0457 ; 0000-0002-3727-326X ; 0000-0002-7179-5520</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10522081/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10522081/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,733,786,790,891,27957,27958,53827,53829</link.rule.ids></links><search><creatorcontrib>Bayrasheva, Valentina K.</creatorcontrib><creatorcontrib>Pchelin, Ivan Y.</creatorcontrib><creatorcontrib>Dobronravov, Vladimir A.</creatorcontrib><creatorcontrib>Babenko, Alina Yu</creatorcontrib><creatorcontrib>Chefu, Svetlana G.</creatorcontrib><creatorcontrib>Shatalov, Ivan S.</creatorcontrib><creatorcontrib>Vasilkova, Volha N.</creatorcontrib><creatorcontrib>Hudiakova, Natalia V.</creatorcontrib><creatorcontrib>Ivanova, Alexandra N.</creatorcontrib><creatorcontrib>Andoskin, Pavel A.</creatorcontrib><creatorcontrib>Grineva, Elena N.</creatorcontrib><title>Short-term renal and metabolic effects of low dose vildagliptin treatment added-on insulin therapy in non-proteinuric patients with type 2 diabetes: open-label randomized prospective study</title><title>Archives of Endocrinology and Metabolism</title><description>ABSTRACT Objective The aim of this randomized comparative study was to assess renal and metabolic effects of vildagliptin in insulin-treated type 2 diabetes (T2DM) patients without overt chronic kidney disease. Subjects and methods We randomized 47 insulin-treated non-proteinuric patients with satisfactory controlled T2DM and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 either to continue insulin therapy (control) or to receive combined insulin-vildagliptin treatment (VIG group). We assessed eGFR using serum creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys), and urinary creatinine-adjusted excretion of albumin (UACR), type IV collagen (uCol IV/Cr), and neutrophil gelatinase-associated lipocalin (uNGAL/Cr) at baseline and after 6 months of treatment. Results Study groups were comparable in terms of age and sex (60.1 ± 6.1 years and 42.9% men in control group vs. 60.8 ± 5.2 years and 39.1% in VIG group). After 6 months of treatment, there were no significant changes in main assessed parameters in control group. VIG group demonstrated significant decrease in HbA1c, diastolic blood pressure, frequency of hypoglycemia, and high-sensitivity C-reactive protein level as compared to the changes in control group. While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p &lt; 0.01 each). Correlation and regression analysis revealed glucose-independent pattern of these changes. Conclusion Addition of vildagliptin to ongoing insulin therapy in patients with T2DM was associated with a reduction in uCol IV/Cr and an increase in eGFRcys and eGFRcreat-cys, independent of T2DM control parameters.</description><subject>cystatin C</subject><subject>NGAL</subject><subject>Original</subject><subject>renal function</subject><subject>type 2 diabetes</subject><subject>type IV collagen</subject><subject>Vildagliptin</subject><issn>2359-3997</issn><issn>2359-4292</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpVks1qGzEQgJfS0oQ0T9CLXmBb_e5auYQS2iQQ6KG5L7Orka2glRZJdnCfrQ9X2Q4BD4LR_H0MM9M0Xxn9xqmW6jsXSrdC654ehXP6obk8OiXX_OPb_5Bw0Vzn_FJzmGKMSfW5uRCcd72Qq8vm359NTKUtmGaSMIAnEAyZscAYvZsIWotTySRa4uMrMTEj2TlvYO3dUlwgJSGUGUMhYAyaNgbiQt76Q2iDCZZ9tUmIoV1SLOjCNlXsAsXVmkxeXdmQsl-QcGIcjFgw35C4YGh9tTxJtZ84u79oSAXkpXbjdkhy2Zr9l-aTBZ_x-k1fNc-_fj7fPbRPv-8f7348tZPsWGmNEbqXHKRhasKV7KlRKDsLKC0w2hs6SgUjr69n3EpOqZVjD9xYjUKKq-bxhDURXoYluRnSfojghqMjpvUAqbjJ44CCK1BSwsQ6KTXX46ix42IEZXvLusq6PbGW7TijmeoQEvgz6HkkuM2wjruBUVV3vGKVIE6EqY4jJ7TvxYwOx9sYDqsfzm5D_Aen57C8</recordid><startdate>20200801</startdate><enddate>20200801</enddate><creator>Bayrasheva, Valentina K.</creator><creator>Pchelin, Ivan Y.</creator><creator>Dobronravov, Vladimir A.</creator><creator>Babenko, Alina Yu</creator><creator>Chefu, Svetlana G.</creator><creator>Shatalov, Ivan S.</creator><creator>Vasilkova, Volha N.</creator><creator>Hudiakova, Natalia V.</creator><creator>Ivanova, Alexandra N.</creator><creator>Andoskin, Pavel A.</creator><creator>Grineva, Elena N.</creator><general>Sociedade Brasileira de Endocrinologia e Metabologia</general><general>Brazilian Society of Endocrinology and Metabolism</general><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-0559-697X</orcidid><orcidid>https://orcid.org/0000-0002-6956-9014</orcidid><orcidid>https://orcid.org/0000-0002-1180-3365</orcidid><orcidid>https://orcid.org/0000-0002-9249-660X</orcidid><orcidid>https://orcid.org/0000-0002-1676-5898</orcidid><orcidid>https://orcid.org/0000-0001-8529-3890</orcidid><orcidid>https://orcid.org/0000-0002-7034-0962</orcidid><orcidid>https://orcid.org/0000-0003-0042-7680</orcidid><orcidid>https://orcid.org/0000-0003-0187-0457</orcidid><orcidid>https://orcid.org/0000-0002-3727-326X</orcidid><orcidid>https://orcid.org/0000-0002-7179-5520</orcidid></search><sort><creationdate>20200801</creationdate><title>Short-term renal and metabolic effects of low dose vildagliptin treatment added-on insulin therapy in non-proteinuric patients with type 2 diabetes: open-label randomized prospective study</title><author>Bayrasheva, Valentina K. ; Pchelin, Ivan Y. ; Dobronravov, Vladimir A. ; Babenko, Alina Yu ; Chefu, Svetlana G. ; Shatalov, Ivan S. ; Vasilkova, Volha N. ; Hudiakova, Natalia V. ; Ivanova, Alexandra N. ; Andoskin, Pavel A. ; Grineva, Elena N.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c461t-dd39742a4d15ce8470d5e46fae4fa107d0b45ab2ab2712f4200f4b7a2df9e343</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>cystatin C</topic><topic>NGAL</topic><topic>Original</topic><topic>renal function</topic><topic>type 2 diabetes</topic><topic>type IV collagen</topic><topic>Vildagliptin</topic><toplevel>online_resources</toplevel><creatorcontrib>Bayrasheva, Valentina K.</creatorcontrib><creatorcontrib>Pchelin, Ivan Y.</creatorcontrib><creatorcontrib>Dobronravov, Vladimir A.</creatorcontrib><creatorcontrib>Babenko, Alina Yu</creatorcontrib><creatorcontrib>Chefu, Svetlana G.</creatorcontrib><creatorcontrib>Shatalov, Ivan S.</creatorcontrib><creatorcontrib>Vasilkova, Volha N.</creatorcontrib><creatorcontrib>Hudiakova, Natalia V.</creatorcontrib><creatorcontrib>Ivanova, Alexandra N.</creatorcontrib><creatorcontrib>Andoskin, Pavel A.</creatorcontrib><creatorcontrib>Grineva, Elena N.</creatorcontrib><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Archives of Endocrinology and Metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bayrasheva, Valentina K.</au><au>Pchelin, Ivan Y.</au><au>Dobronravov, Vladimir A.</au><au>Babenko, Alina Yu</au><au>Chefu, Svetlana G.</au><au>Shatalov, Ivan S.</au><au>Vasilkova, Volha N.</au><au>Hudiakova, Natalia V.</au><au>Ivanova, Alexandra N.</au><au>Andoskin, Pavel A.</au><au>Grineva, Elena N.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Short-term renal and metabolic effects of low dose vildagliptin treatment added-on insulin therapy in non-proteinuric patients with type 2 diabetes: open-label randomized prospective study</atitle><jtitle>Archives of Endocrinology and Metabolism</jtitle><date>2020-08-01</date><risdate>2020</risdate><volume>64</volume><issue>4</issue><spage>418</spage><epage>426</epage><pages>418-426</pages><issn>2359-3997</issn><eissn>2359-4292</eissn><notes>Disclosure: V. Bayrasheva received honoraria for scientific presentation and lectures from Novartis. V. Dobronravov received lecture fees from Alexion, Amgen, Abvie, Aurinia, Roche. A. Babenko and E. Grineva received honoraria for lectures, conferences and presentations at satellite symposia by Sanofi-Aventis, Novartis, Eli Lilly, Novo Nordisk, Abbott, Merck, Roche. V. Vasilkova received honoraria for symposia sponsored by Sanofi-Aventis. Other co-authors reported no conflict of interests.</notes><abstract>ABSTRACT Objective The aim of this randomized comparative study was to assess renal and metabolic effects of vildagliptin in insulin-treated type 2 diabetes (T2DM) patients without overt chronic kidney disease. Subjects and methods We randomized 47 insulin-treated non-proteinuric patients with satisfactory controlled T2DM and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 either to continue insulin therapy (control) or to receive combined insulin-vildagliptin treatment (VIG group). We assessed eGFR using serum creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys), and urinary creatinine-adjusted excretion of albumin (UACR), type IV collagen (uCol IV/Cr), and neutrophil gelatinase-associated lipocalin (uNGAL/Cr) at baseline and after 6 months of treatment. Results Study groups were comparable in terms of age and sex (60.1 ± 6.1 years and 42.9% men in control group vs. 60.8 ± 5.2 years and 39.1% in VIG group). After 6 months of treatment, there were no significant changes in main assessed parameters in control group. VIG group demonstrated significant decrease in HbA1c, diastolic blood pressure, frequency of hypoglycemia, and high-sensitivity C-reactive protein level as compared to the changes in control group. While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p &lt; 0.01 each). Correlation and regression analysis revealed glucose-independent pattern of these changes. Conclusion Addition of vildagliptin to ongoing insulin therapy in patients with T2DM was associated with a reduction in uCol IV/Cr and an increase in eGFRcys and eGFRcreat-cys, independent of T2DM control parameters.</abstract><pub>Sociedade Brasileira de Endocrinologia e Metabologia</pub><pmid>32267348</pmid><doi>10.20945/2359-3997000000220</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-0559-697X</orcidid><orcidid>https://orcid.org/0000-0002-6956-9014</orcidid><orcidid>https://orcid.org/0000-0002-1180-3365</orcidid><orcidid>https://orcid.org/0000-0002-9249-660X</orcidid><orcidid>https://orcid.org/0000-0002-1676-5898</orcidid><orcidid>https://orcid.org/0000-0001-8529-3890</orcidid><orcidid>https://orcid.org/0000-0002-7034-0962</orcidid><orcidid>https://orcid.org/0000-0003-0042-7680</orcidid><orcidid>https://orcid.org/0000-0003-0187-0457</orcidid><orcidid>https://orcid.org/0000-0002-3727-326X</orcidid><orcidid>https://orcid.org/0000-0002-7179-5520</orcidid><oa>free_for_read</oa></addata></record>
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subjects cystatin C
NGAL
Original
renal function
type 2 diabetes
type IV collagen
Vildagliptin
title Short-term renal and metabolic effects of low dose vildagliptin treatment added-on insulin therapy in non-proteinuric patients with type 2 diabetes: open-label randomized prospective study
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