SGLT2i agonist plus GLP-1 receptor COMBination therapy in type 2 diabetes: a renal (KIDney) endpoints real world study-(COMBi-KID Study). (Preprint)

2021 ◽  
Author(s):  
Michael David Feher ◽  
Mark Joy ◽  
William Hinton ◽  
Neil Munro ◽  
david wheeler ◽  
...  

BACKGROUND Sodium-glucose co-transporter-2 inhibitor (SGLT2i)s and glucagon-like peptide-1 receptor agonist (GLP-1RA)s are both considered to be standard care in the management of glycaemia in type 2 diabetes. Recent trial evidence has indicated benefits on primary renal endpoints for individual drugs within each medication class. Despite potential benefits of combining SGLT2i and GLP-1RA for glycaemia management according to national/international guideline recommendations, there is currently limited data on renal endpoints for this drug combination. OBJECTIVE To assess the real-world effects of combining SGLT2i and GLP-1 RA therapies on renal end-points, glycaemic control and weight in people with type 2 diabetes currently treated with renin-angiotensin system (RAS) blockade medication. METHODS This retrospective cohort study will utilise electronic health records of people with type 2 diabetes registered with general practices covering over 15million people in England and Wales and included in the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. A propensity score matched cohort of new users of SGLT2is, GLP-1 RAs, and those prescribed SGLT2is and GLP-1 RAs in combination, will be identified. These will be matched on drug history, comorbidities and demographics. A repeated measures multilevel, linear regression analysis will be performed to compare mean change (from baseline) in estimated glomerular filtration rate (eGFR) at 12 and 24 months between those switched onto combined therapy and those prescribed monotherapy of SGLT2i or GLP-1 RA. Secondary end points will be albuminuria, serum creatinine, glycated haemoglobin, body mass index will be similarly assessed for change at follow up. RESULTS The study proposal was approved by the Medical Sciences Interdivisional Research Ethics Committee, University Oxford in August 2021 (R76885/RE001). The study is due to be commenced October 2021 and expected completion by March 2020 CONCLUSIONS The present study will be one of the first to assess the combination of SGLT2i and GLP-1RA therapy for type 2 diabetes management and renal effects as primary endpoint in type 2 diabetes from a real-world perspective.

2012 ◽  
Vol 38 (3) ◽  
pp. 409-416 ◽  
Author(s):  
Matthew J. Pepper ◽  
Natohya Mallory ◽  
T. Nicole Coker ◽  
Amber Chaki ◽  
Karen R. Sando

Purpose The purpose of this study was to evaluate a diabetes education program that includes a pharmacist as a member of the diabetes management team by assessing the change in hemoglobin A1c (A1C), cholesterol, and blood pressure for patients with type 2 diabetes in outpatient clinics. Methods This was a retrospective study in outpatient clinics at Shands Jacksonville Medical Center. The patients were assigned into either the pharmacist group or the nonpharmacist group, according to the presence or the absence of a pharmacist in the clinic. The primary end point was the absolute change in A1C versus baseline. Secondary end points included change in cholesterol and blood pressure and the number of patients to attain American Diabetes Association goals. End points were recorded to correlate within 3 months of the initial visit and final visit with a provider. Results Compared to the nonpharmacist group, patients in the pharmacist group had more advanced and uncontrolled diabetes at baseline. The pharmacist group showed a greater percent change in A1C and improvement between the initial and final clinic visits, after adjusting for baseline confounders. Despite the statistically significant improvement in A1C in the pharmacist group, there was no difference found between the 2 groups for the end points of cholesterol and blood pressure. Conclusion Including a pharmacist as a part of the diabetes management team may result in lower A1C in patients with more advanced and uncontrolled type 2 diabetes mellitus versus a health care team without a pharmacist.


Diabetologia ◽  
2020 ◽  
Vol 63 (4) ◽  
pp. 711-721 ◽  
Author(s):  
Pablo Aschner ◽  
Juan J. Gagliardino ◽  
Hasan Ilkova ◽  
Fernando Lavalle ◽  
Ambady Ramachandran ◽  
...  

Abstract Aims/hypothesis We evaluated the secular trend of glycaemic control in individuals with type 2 diabetes in developing countries, where data are limited. Methods The International Diabetes Management Practices Study provides real-world evidence of patient profiles and diabetes care practices in developing countries in seven cross-sectional waves (2005–2017). At each wave, each physician collected data from ten consecutive participants with type 2 diabetes during a 2 week period. The primary objective of this analysis was to evaluate trends of glycaemic control over time. Results A total of 66,088 individuals with type 2 diabetes were recruited by 6099 physicians from 49 countries. The proportion of participants with HbA1c <53 mmol/mol (<7%) decreased from 36% in wave 1 (2005) to 30.1% in wave 7 (2017) (p < 0.0001). Compared with wave 1, the adjusted ORs of attaining HbA1c ≤64 mmol/mol (≤8%) decreased significantly in waves 2, 5, 6 and 7 (p < 0.05). Over 80% of participants received oral glucose-lowering drugs, with declining use of sulfonylureas. Insulin use increased from 32.8% (wave 1) to 41.2% (wave 7) (p < 0.0001). The corresponding time to insulin initiation (mean ± SD) changed from 8.4 ± 6.9 in wave 1 to 8.3 ± 6.6 years in wave 7, while daily insulin dosage ranged from 0.39 ± 0.21 U/kg (wave 1) to 0.33 ± 0.19 U/kg (wave 7) for basal regimen and 0.70 ± 0.34 U/kg (wave 1) to 0.77 ± 0.33 (wave 7) U/kg for basal–bolus regimen. An increasing proportion of participants had ≥2 HbA1c measurements within 12 months of enrolment (from 61.8% to 92.9%), and the proportion of participants receiving diabetes education (mainly delivered by physicians) also increased from 59.0% to 78.3%. Conclusions In developing countries, glycaemic control in individuals with type 2 diabetes remained suboptimal over a 12 year period, indicating a need for system changes and better organisation of care to improve self-management and attainment of treatment goals.


2021 ◽  
Vol 14 ◽  
pp. 117955142110305
Author(s):  
Ashok Kumar Das ◽  
Sanjiv Shah ◽  
Santosh Kumar Singh ◽  
Archana Juneja ◽  
Niroj Kumar Mishra ◽  
...  

Background: To evaluate the clinical characteristics, treatment patterns, and clinical effectiveness and safety of high doses of metformin (1500-2500 mg/day) in Indian adults with type 2 diabetes mellitus (T2DM). Materials and methods: A retrospective, multicentric (n = 241), real-world study included patients with T2DM (aged >18 years) receiving high doses of metformin. Details were retrieved from patient’s medical records. Results: Out of 5695 patients, 62.7% were men with median age was 50.0 years. Hypertension (67.5%) and dyslipidemia (48.7%) were the prevalent comorbidities. Doses of 2000 mg (57.4%) and 1500 mg (29.1%) were the most commonly used doses of metformin and median duration of high-dose metformin therapy was 24.0 months. Metformin twice daily was the most frequently used dosage pattern (94.2%). Up-titration of doses was done in 96.8% of patients. The mean HbA1c levels were significantly decreased post-treatment (mean change: 1.08%; P < .001). The target glycemic control was achieved in 91.2% patients. A total of 83.0% had decreased weight. Adverse events were reported in 156 patients. Physician global evaluation of efficacy and tolerability showed majority of patients on a good to excellent scale (98.2% and 97.7%). Conclusion: Clinical effectiveness and safety of a high-dose metformin was demonstrated through significant improvement in HbA1c levels and weight reduction.


2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Kenichi Tanaka ◽  
Yosuke Okada ◽  
Akemi Tokutsu ◽  
Yoshiya Tanaka

AbstractReal-world data comparing the effectiveness of various glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in type 2 diabetes mellitus (T2DM) are limited. We investigated the clinical effectiveness of liraglutide and dulaglutide in Japanese T2DM in a real-world setting. This retrospective study included 179 patients with T2DM who were treated with GLP-1 RA for at least 12 months (liraglutide, n = 97; dulaglutide, n = 82). We used stabilized propensity score-based inverse probability of treatment weighting (IPTW) to reduce selection bias and confounding by observed covariates. Changes in glycated hemoglobin (HbA1c) at the end of the 12-month treatment were evaluated. After adjustment by stabilized propensity score-based IPTW, no significant differences were observed in patient characteristics between the liraglutide and dulaglutide groups. HbA1c was significantly lower at 12 months in both groups (liraglutide, 8.9 to 7.4%; dulaglutide, 8.7 to 7.5%). Multivariate linear regression analysis showed no differences in the extent of changes in HbA1c at 12 months between the two agents. High baseline HbA1c, the addition of GLP-1 RA treatment modality, and in-hospital initiation of GLP-1 RA treatment were identified as significant contributing factors to HbA1c reduction. The effects of liraglutide and dulaglutide on lowering HbA1c levels at 12 months were comparable in a real-world setting.


2017 ◽  
Vol 7 ◽  
pp. 21-27 ◽  
Author(s):  
Margaret McGill ◽  
Lawrence Blonde ◽  
Juliana C.N. Chan ◽  
Kamlesh Khunti ◽  
Fernando J. Lavalle ◽  
...  

Diabetes Care ◽  
2018 ◽  
Vol 41 (7) ◽  
pp. e113-e114 ◽  
Author(s):  
Kevin M. Pantalone ◽  
Anita D. Misra-Hebert ◽  
Todd M. Hobbs ◽  
Xinge Ji ◽  
Sheldon X. Kong ◽  
...  

2018 ◽  
Vol 42 (5) ◽  
pp. S44-S45
Author(s):  
Alan Bell ◽  
Ronald Goldenberg ◽  
Willoon Cheng ◽  
Angela Karellis ◽  
John Sampalis ◽  
...  

2017 ◽  
Vol 12 (3) ◽  
pp. 701-708 ◽  
Author(s):  
Reid Offringa ◽  
Tong Sheng ◽  
Linda Parks ◽  
Mark Clements ◽  
David Kerr ◽  
...  

Background: Diabetes is a chronic condition that requires constant self-management. As a consequence, several software platforms have been developed to facilitate the tracking of diabetes data to improve diabetes management. Our aim was to determine the real-world glycemic benefits of a mobile diabetes management platform used by individuals with type 1 and type 2 diabetes. Methods: Mobile platform-using (n = 899) and control (n = 900) participants meeting specific minimum data criteria were randomly selected from a database of diabetes users. All results were modeled using different mixed effect generalized linear models, assigning random intercepts for each user, and adjusting the distribution assumption for each outcome. Results: Users of the mobile platform increased their frequency of blood glucose monitoring (+8.8 tests per month, 95% CI [3.4, 14.1], P < .001) and had fewer hyperglycemic events and lower average glucose levels compared to the control group. In addition, a mobile user could expect a 3.5% drop in average BG (−6.4 mg/dL, 95% CI [−2.0, −10.7], P < .001) and a 10.7% decrease in hyperglycemia ( P < .001) after 2 months. Conclusion: Users of the mobile platform tested their BG more often and demonstrated greater improvement in blood glucose compared to users who did not use the mobile platform. This supports previous studies indicating that digital technologies can enhance diabetes care in a real-world setting.


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