A double‐blind, Randomized controlled trial on glucose‐lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase‐4 inhibitor therapy: REFIND study
Aims To compare the efficacy and safety of adding low‐dose lobeglitazone (0.25 mg/day) or standard‐dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy. Materials and Methods In...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2022-09, Vol.24 (9), p.1800-1809 |
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| creator | Ryang, Soree Kim, Sang Soo Bae, Ji Cheol Han, Ji Min Kwon, Su Kyoung Kim, Young Il Nam‐Goong, Il Seong Kim, Eun Sook Kim, Mi‐kyung Lee, Chang Won Yoo, Soyeon Koh, Gwanpyo Kwon, Min Jeong Park, Jeong Hyun Kim, In Joo |
| description | Aims
To compare the efficacy and safety of adding low‐dose lobeglitazone (0.25 mg/day) or standard‐dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy.
Materials and Methods
In this phase 4, multicentre, double‐blind, randomized controlled, non‐inferiority trial, patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy were randomized to receive either low‐dose or standard‐dose lobeglitazone. The primary endpoint was non‐inferiority of low‐dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated haemoglobin levels at week 24 relative to baseline values and compared with standard‐dose lobeglitazone, using 0.5% non‐inferiority margin.
Results
At week 24, the mean glycated haemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low‐dose and standard‐dose lobeglitazone groups, respectively (p = .031). The between‐group difference was 0.18% (95% confidence interval 0.017‐0.345), showing non‐inferiority of the low‐dose lobeglitazone. Mean body weight changes were significantly greater in the standard‐dose group (1.36 ± 2.23 kg) than in the low‐dose group (0.50 ± 1.85 kg) at week 24. The changes in HOMA‐IR, lipid profile and liver enzyme levels showed no significant difference between the groups. Overall treatment‐emergent adverse events (including weight gain, oedema and hypoglycaemia) occurred more frequently in the standard‐dose group.
Conclusions
Adding low‐dose lobeglitazone to metformin and DPP4 inhibitor combination resulted in a non‐inferior glucose‐lowering outcome and fewer adverse events compared with standard‐dose lobeglitazone. Therefore, low‐dose lobeglitazone might be one option for individualized strategy in patients with T2DM. |
| doi_str_mv | 10.1111/dom.14766 |
| format | Article |
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To compare the efficacy and safety of adding low‐dose lobeglitazone (0.25 mg/day) or standard‐dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy.
Materials and Methods
In this phase 4, multicentre, double‐blind, randomized controlled, non‐inferiority trial, patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy were randomized to receive either low‐dose or standard‐dose lobeglitazone. The primary endpoint was non‐inferiority of low‐dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated haemoglobin levels at week 24 relative to baseline values and compared with standard‐dose lobeglitazone, using 0.5% non‐inferiority margin.
Results
At week 24, the mean glycated haemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low‐dose and standard‐dose lobeglitazone groups, respectively (p = .031). The between‐group difference was 0.18% (95% confidence interval 0.017‐0.345), showing non‐inferiority of the low‐dose lobeglitazone. Mean body weight changes were significantly greater in the standard‐dose group (1.36 ± 2.23 kg) than in the low‐dose group (0.50 ± 1.85 kg) at week 24. The changes in HOMA‐IR, lipid profile and liver enzyme levels showed no significant difference between the groups. Overall treatment‐emergent adverse events (including weight gain, oedema and hypoglycaemia) occurred more frequently in the standard‐dose group.
Conclusions
Adding low‐dose lobeglitazone to metformin and DPP4 inhibitor combination resulted in a non‐inferior glucose‐lowering outcome and fewer adverse events compared with standard‐dose lobeglitazone. Therefore, low‐dose lobeglitazone might be one option for individualized strategy in patients with T2DM.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.14766</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adverse events ; antidiabetic drugs ; Antidiabetics ; beta‐cell function ; Body weight ; Body weight gain ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Double-blind studies ; Edema ; Glucose ; glycaemic control ; Hemoglobin ; Hypoglycemia ; Metformin ; Patients ; Peptidase ; thiazolidinediones ; type 2 diabetes</subject><ispartof>Diabetes, obesity & metabolism, 2022-09, Vol.24 (9), p.1800-1809</ispartof><rights>2022 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2022. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3656-383b4a21aad91d76a4ab695fb01f8d9e686a52bbe7817595e589ce047224ee2c3</citedby><cites>FETCH-LOGICAL-c3656-383b4a21aad91d76a4ab695fb01f8d9e686a52bbe7817595e589ce047224ee2c3</cites><orcidid>0000-0002-6184-7171 ; 0000-0002-5251-5554 ; 0000-0002-9687-8357 ; 0000-0002-0492-0467 ; 0000-0002-6020-2777 ; 0000-0003-1765-0774 ; 0000-0002-2960-1040 ; 0000-0002-9311-4642 ; 0000-0002-7881-9732 ; 0000-0002-4763-5797 ; 0000-0002-0045-4438 ; 0000-0003-1111-9122 ; 0000-0002-9616-870X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.14766$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.14766$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids></links><search><creatorcontrib>Ryang, Soree</creatorcontrib><creatorcontrib>Kim, Sang Soo</creatorcontrib><creatorcontrib>Bae, Ji Cheol</creatorcontrib><creatorcontrib>Han, Ji Min</creatorcontrib><creatorcontrib>Kwon, Su Kyoung</creatorcontrib><creatorcontrib>Kim, Young Il</creatorcontrib><creatorcontrib>Nam‐Goong, Il Seong</creatorcontrib><creatorcontrib>Kim, Eun Sook</creatorcontrib><creatorcontrib>Kim, Mi‐kyung</creatorcontrib><creatorcontrib>Lee, Chang Won</creatorcontrib><creatorcontrib>Yoo, Soyeon</creatorcontrib><creatorcontrib>Koh, Gwanpyo</creatorcontrib><creatorcontrib>Kwon, Min Jeong</creatorcontrib><creatorcontrib>Park, Jeong Hyun</creatorcontrib><creatorcontrib>Kim, In Joo</creatorcontrib><title>A double‐blind, Randomized controlled trial on glucose‐lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase‐4 inhibitor therapy: REFIND study</title><title>Diabetes, obesity & metabolism</title><description>Aims
To compare the efficacy and safety of adding low‐dose lobeglitazone (0.25 mg/day) or standard‐dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy.
Materials and Methods
In this phase 4, multicentre, double‐blind, randomized controlled, non‐inferiority trial, patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy were randomized to receive either low‐dose or standard‐dose lobeglitazone. The primary endpoint was non‐inferiority of low‐dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated haemoglobin levels at week 24 relative to baseline values and compared with standard‐dose lobeglitazone, using 0.5% non‐inferiority margin.
Results
At week 24, the mean glycated haemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low‐dose and standard‐dose lobeglitazone groups, respectively (p = .031). The between‐group difference was 0.18% (95% confidence interval 0.017‐0.345), showing non‐inferiority of the low‐dose lobeglitazone. Mean body weight changes were significantly greater in the standard‐dose group (1.36 ± 2.23 kg) than in the low‐dose group (0.50 ± 1.85 kg) at week 24. The changes in HOMA‐IR, lipid profile and liver enzyme levels showed no significant difference between the groups. Overall treatment‐emergent adverse events (including weight gain, oedema and hypoglycaemia) occurred more frequently in the standard‐dose group.
Conclusions
Adding low‐dose lobeglitazone to metformin and DPP4 inhibitor combination resulted in a non‐inferior glucose‐lowering outcome and fewer adverse events compared with standard‐dose lobeglitazone. Therefore, low‐dose lobeglitazone might be one option for individualized strategy in patients with T2DM.</description><subject>Adverse events</subject><subject>antidiabetic drugs</subject><subject>Antidiabetics</subject><subject>beta‐cell function</subject><subject>Body weight</subject><subject>Body weight gain</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Double-blind studies</subject><subject>Edema</subject><subject>Glucose</subject><subject>glycaemic control</subject><subject>Hemoglobin</subject><subject>Hypoglycemia</subject><subject>Metformin</subject><subject>Patients</subject><subject>Peptidase</subject><subject>thiazolidinediones</subject><subject>type 2 diabetes</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1ksFu1DAQhiMEEqVw4A1G4gJSs00cx0m4Ve0urFRaqYJzZMeTXVdOnNqOVumJR-AReBYehefggLOBCxK-zEjz_f_8kieKXqfJKg3vXJpuldKCsSfRSUpZFqcZYU-PPYnLKiHPoxfO3SdJQrOyOIl-XYA0o9D48-s3oVUvz-CO98FFPaKExvTeGq1D663iGkwPOz02xs28Nge0qt_BetNi4x0EITjeop_AtMClnIfJiuRgbKj5j-_dDrQRuNPK80fTI6ge_DQgEJCKC_ToYOBeYR_sDsrvYXvDJT6M3OPfNHOIDn1rbBfU806pBhy8kpOGpeHHfDS475VQPmz3e7R8mN7D3XqzvbkC50c5vYyetVw7fPWnnkZfNuvPlx_j69sP28uL67jJWM7irMwE5STlXFapLBinXLAqb0WStqWskJWM50QILMq0yKsc87JqMKEFIRSRNNlp9HbxHax5GNH5ulOuQa15j2Z0NWGM5bQkpAjom3_QezPaPqQLVFUkrGCUBOrdQjXWOGexrQerOm6nOk3q-Q7q8IP18Q4Ce76wB6Vx-j9YX91-WhS_Af-pu9M</recordid><startdate>202209</startdate><enddate>202209</enddate><creator>Ryang, Soree</creator><creator>Kim, Sang Soo</creator><creator>Bae, Ji Cheol</creator><creator>Han, Ji Min</creator><creator>Kwon, Su Kyoung</creator><creator>Kim, Young Il</creator><creator>Nam‐Goong, Il Seong</creator><creator>Kim, Eun Sook</creator><creator>Kim, Mi‐kyung</creator><creator>Lee, Chang Won</creator><creator>Yoo, Soyeon</creator><creator>Koh, Gwanpyo</creator><creator>Kwon, Min Jeong</creator><creator>Park, Jeong Hyun</creator><creator>Kim, In Joo</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-6184-7171</orcidid><orcidid>https://orcid.org/0000-0002-5251-5554</orcidid><orcidid>https://orcid.org/0000-0002-9687-8357</orcidid><orcidid>https://orcid.org/0000-0002-0492-0467</orcidid><orcidid>https://orcid.org/0000-0002-6020-2777</orcidid><orcidid>https://orcid.org/0000-0003-1765-0774</orcidid><orcidid>https://orcid.org/0000-0002-2960-1040</orcidid><orcidid>https://orcid.org/0000-0002-9311-4642</orcidid><orcidid>https://orcid.org/0000-0002-7881-9732</orcidid><orcidid>https://orcid.org/0000-0002-4763-5797</orcidid><orcidid>https://orcid.org/0000-0002-0045-4438</orcidid><orcidid>https://orcid.org/0000-0003-1111-9122</orcidid><orcidid>https://orcid.org/0000-0002-9616-870X</orcidid></search><sort><creationdate>202209</creationdate><title>A double‐blind, Randomized controlled trial on glucose‐lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase‐4 inhibitor therapy: REFIND study</title><author>Ryang, Soree ; Kim, Sang Soo ; Bae, Ji Cheol ; Han, Ji Min ; Kwon, Su Kyoung ; Kim, Young Il ; Nam‐Goong, Il Seong ; Kim, Eun Sook ; Kim, Mi‐kyung ; Lee, Chang Won ; Yoo, Soyeon ; Koh, Gwanpyo ; Kwon, Min Jeong ; Park, Jeong Hyun ; Kim, In Joo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3656-383b4a21aad91d76a4ab695fb01f8d9e686a52bbe7817595e589ce047224ee2c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adverse events</topic><topic>antidiabetic drugs</topic><topic>Antidiabetics</topic><topic>beta‐cell function</topic><topic>Body weight</topic><topic>Body weight gain</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Double-blind studies</topic><topic>Edema</topic><topic>Glucose</topic><topic>glycaemic control</topic><topic>Hemoglobin</topic><topic>Hypoglycemia</topic><topic>Metformin</topic><topic>Patients</topic><topic>Peptidase</topic><topic>thiazolidinediones</topic><topic>type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ryang, Soree</creatorcontrib><creatorcontrib>Kim, Sang Soo</creatorcontrib><creatorcontrib>Bae, Ji Cheol</creatorcontrib><creatorcontrib>Han, Ji Min</creatorcontrib><creatorcontrib>Kwon, Su Kyoung</creatorcontrib><creatorcontrib>Kim, Young Il</creatorcontrib><creatorcontrib>Nam‐Goong, Il Seong</creatorcontrib><creatorcontrib>Kim, Eun Sook</creatorcontrib><creatorcontrib>Kim, Mi‐kyung</creatorcontrib><creatorcontrib>Lee, Chang Won</creatorcontrib><creatorcontrib>Yoo, Soyeon</creatorcontrib><creatorcontrib>Koh, Gwanpyo</creatorcontrib><creatorcontrib>Kwon, Min Jeong</creatorcontrib><creatorcontrib>Park, Jeong Hyun</creatorcontrib><creatorcontrib>Kim, In Joo</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ryang, Soree</au><au>Kim, Sang Soo</au><au>Bae, Ji Cheol</au><au>Han, Ji Min</au><au>Kwon, Su Kyoung</au><au>Kim, Young Il</au><au>Nam‐Goong, Il Seong</au><au>Kim, Eun Sook</au><au>Kim, Mi‐kyung</au><au>Lee, Chang Won</au><au>Yoo, Soyeon</au><au>Koh, Gwanpyo</au><au>Kwon, Min Jeong</au><au>Park, Jeong Hyun</au><au>Kim, In Joo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A double‐blind, Randomized controlled trial on glucose‐lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase‐4 inhibitor therapy: REFIND study</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><date>2022-09</date><risdate>2022</risdate><volume>24</volume><issue>9</issue><spage>1800</spage><epage>1809</epage><pages>1800-1809</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract>Aims
To compare the efficacy and safety of adding low‐dose lobeglitazone (0.25 mg/day) or standard‐dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy.
Materials and Methods
In this phase 4, multicentre, double‐blind, randomized controlled, non‐inferiority trial, patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy were randomized to receive either low‐dose or standard‐dose lobeglitazone. The primary endpoint was non‐inferiority of low‐dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated haemoglobin levels at week 24 relative to baseline values and compared with standard‐dose lobeglitazone, using 0.5% non‐inferiority margin.
Results
At week 24, the mean glycated haemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low‐dose and standard‐dose lobeglitazone groups, respectively (p = .031). The between‐group difference was 0.18% (95% confidence interval 0.017‐0.345), showing non‐inferiority of the low‐dose lobeglitazone. Mean body weight changes were significantly greater in the standard‐dose group (1.36 ± 2.23 kg) than in the low‐dose group (0.50 ± 1.85 kg) at week 24. The changes in HOMA‐IR, lipid profile and liver enzyme levels showed no significant difference between the groups. Overall treatment‐emergent adverse events (including weight gain, oedema and hypoglycaemia) occurred more frequently in the standard‐dose group.
Conclusions
Adding low‐dose lobeglitazone to metformin and DPP4 inhibitor combination resulted in a non‐inferior glucose‐lowering outcome and fewer adverse events compared with standard‐dose lobeglitazone. Therefore, low‐dose lobeglitazone might be one option for individualized strategy in patients with T2DM.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><doi>10.1111/dom.14766</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-6184-7171</orcidid><orcidid>https://orcid.org/0000-0002-5251-5554</orcidid><orcidid>https://orcid.org/0000-0002-9687-8357</orcidid><orcidid>https://orcid.org/0000-0002-0492-0467</orcidid><orcidid>https://orcid.org/0000-0002-6020-2777</orcidid><orcidid>https://orcid.org/0000-0003-1765-0774</orcidid><orcidid>https://orcid.org/0000-0002-2960-1040</orcidid><orcidid>https://orcid.org/0000-0002-9311-4642</orcidid><orcidid>https://orcid.org/0000-0002-7881-9732</orcidid><orcidid>https://orcid.org/0000-0002-4763-5797</orcidid><orcidid>https://orcid.org/0000-0002-0045-4438</orcidid><orcidid>https://orcid.org/0000-0003-1111-9122</orcidid><orcidid>https://orcid.org/0000-0002-9616-870X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1462-8902 |
| ispartof | Diabetes, obesity & metabolism, 2022-09, Vol.24 (9), p.1800-1809 |
| issn | 1462-8902 1463-1326 |
| language | eng |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Adverse events antidiabetic drugs Antidiabetics beta‐cell function Body weight Body weight gain Diabetes Diabetes mellitus (non-insulin dependent) Double-blind studies Edema Glucose glycaemic control Hemoglobin Hypoglycemia Metformin Patients Peptidase thiazolidinediones type 2 diabetes |
| title | A double‐blind, Randomized controlled trial on glucose‐lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase‐4 inhibitor therapy: REFIND study |
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