Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study)
BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are both considered to be part of standard care in the management of glycemia in type 2 diabetes. Recent trial evidence has indicated benefits on primary kid...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-07-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/7/e34206 |
| _version_ | 1797734942326652928 |
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| author | Michael Feher William Hinton Anna Forbes Neil Munro Mark Joy David Wheeler Simon de Lusignan |
| author_facet | Michael Feher William Hinton Anna Forbes Neil Munro Mark Joy David Wheeler Simon de Lusignan |
| author_sort | Michael Feher |
| collection | DOAJ |
| description |
BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are both considered to be part of standard care in the management of glycemia in type 2 diabetes. Recent trial evidence has indicated benefits on primary kidney end points for individual drugs within each medication class. Despite the potential benefits of combining SGLT2is and GLP-1RAs for glycemia management, according to national and international guideline recommendations, there is currently limited data on kidney end points for this drug combination.
ObjectiveThe aims of the study are to assess the real-world effects of combination SGLT2i and GLP-1RA therapies for diabetes management on kidney end points, glycemic control, and weight in people with type 2 diabetes who are being treated with renin-angiotensin system blockade medication.
MethodsThis retrospective cohort study will use the electronic health records of people with type 2 diabetes that are registered with general practices covering over 15 million people in England and Wales and are included in the Oxford-Royal College of General Practitioners Research and Surveillance Centre network. A propensity score–matched cohort of prevalent new users of SGLT2is and GLP-1RAs and those who have been prescribed SGLT2is and GLP-1RAs in combination will be identified. They will be matched based on drug histories, comorbidities, and demographics. A repeated-measures, multilevel, linear regression analysis will be performed to compare the mean change (from baseline) in estimated glomerular filtration rate at 12 and 24 months between those who switched to combined therapy and those continuing monotherapy with an SGLT2i or GLP-1RA. The secondary end points will be albuminuria, serum creatinine level, glycated hemoglobin level, and BMI. These will also be assessed for change at the 12- and 24-month follow-ups.
ResultsThe study is due to commence in March 2022 and is expected to be complete by September 2022.
ConclusionsOur study will be the first to assess the impact of combination SGLT2i and GLP-1RA therapy in type 2 diabetes on primary kidney end points from a real-world perspective.
International Registered Report Identifier (IRRID)PRR1-10.2196/34206 |
| first_indexed | 2024-03-12T12:50:46Z |
| format | Article |
| id | doaj.art-a0205d5010e644f6bbbdb05718603378 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:50:46Z |
| publishDate | 2022-07-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-a0205d5010e644f6bbbdb057186033782023-08-28T22:44:01ZengJMIR PublicationsJMIR Research Protocols1929-07482022-07-01117e3420610.2196/34206Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study)Michael Feherhttps://orcid.org/0000-0003-0631-6199William Hintonhttps://orcid.org/0000-0003-4927-0901Anna Forbeshttps://orcid.org/0000-0001-7860-3782Neil Munrohttps://orcid.org/0000-0003-0150-326XMark Joyhttps://orcid.org/0000-0002-4974-3724David Wheelerhttps://orcid.org/0000-0003-0745-3478Simon de Lusignanhttps://orcid.org/0000-0002-8553-2641 BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are both considered to be part of standard care in the management of glycemia in type 2 diabetes. Recent trial evidence has indicated benefits on primary kidney end points for individual drugs within each medication class. Despite the potential benefits of combining SGLT2is and GLP-1RAs for glycemia management, according to national and international guideline recommendations, there is currently limited data on kidney end points for this drug combination. ObjectiveThe aims of the study are to assess the real-world effects of combination SGLT2i and GLP-1RA therapies for diabetes management on kidney end points, glycemic control, and weight in people with type 2 diabetes who are being treated with renin-angiotensin system blockade medication. MethodsThis retrospective cohort study will use the electronic health records of people with type 2 diabetes that are registered with general practices covering over 15 million people in England and Wales and are included in the Oxford-Royal College of General Practitioners Research and Surveillance Centre network. A propensity score–matched cohort of prevalent new users of SGLT2is and GLP-1RAs and those who have been prescribed SGLT2is and GLP-1RAs in combination will be identified. They will be matched based on drug histories, comorbidities, and demographics. A repeated-measures, multilevel, linear regression analysis will be performed to compare the mean change (from baseline) in estimated glomerular filtration rate at 12 and 24 months between those who switched to combined therapy and those continuing monotherapy with an SGLT2i or GLP-1RA. The secondary end points will be albuminuria, serum creatinine level, glycated hemoglobin level, and BMI. These will also be assessed for change at the 12- and 24-month follow-ups. ResultsThe study is due to commence in March 2022 and is expected to be complete by September 2022. ConclusionsOur study will be the first to assess the impact of combination SGLT2i and GLP-1RA therapy in type 2 diabetes on primary kidney end points from a real-world perspective. International Registered Report Identifier (IRRID)PRR1-10.2196/34206https://www.researchprotocols.org/2022/7/e34206 |
| spellingShingle | Michael Feher William Hinton Anna Forbes Neil Munro Mark Joy David Wheeler Simon de Lusignan Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study) JMIR Research Protocols |
| title | Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study) |
| title_full | Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study) |
| title_fullStr | Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study) |
| title_full_unstemmed | Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study) |
| title_short | Sodium-Glucose Cotransporter-2 Inhibitor and Glucagon-Like Peptide-1 Receptor Agonist Combination Therapy in Type 2 Diabetes: Protocol for a Kidney End Points Real-world Study (COMBi-KID Study) |
| title_sort | sodium glucose cotransporter 2 inhibitor and glucagon like peptide 1 receptor agonist combination therapy in type 2 diabetes protocol for a kidney end points real world study combi kid study |
| url | https://www.researchprotocols.org/2022/7/e34206 |
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