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Boye KS, Poon JL, Landó LF, Sapin H, Huh R, Wang M, Williamson S, Patel H. Tirzepatide Improved Health-Related Quality of Life Compared with Insulin Lispro in Basal Insulin-Treated Adults with Type 2 Diabetes and Inadequate Glycaemic Control: A Randomised Controlled Phase 3b Trial (SURPASS-6). Diabetes Ther 2024; 15:2039-2059. [PMID: 39008236 PMCID: PMC11330430 DOI: 10.1007/s13300-024-01620-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Accepted: 07/01/2024] [Indexed: 07/16/2024] Open
Abstract
INTRODUCTION Patients with type 2 diabetes (T2D) who require intensification of basal insulin therapy need treatment options that can improve their health-related quality of life (HRQoL) and translate into better outcomes. These analyses compared patient-reported outcomes (PROs) in patients with T2D receiving tirzepatide or insulin lispro. METHODS The randomised, open-label, multinational, phase 3b SURPASS-6 trial (NCT04537923) was conducted at 135 medical research centres and hospitals in 15 countries and compared two recommended treatment intensification strategies in people with T2D and inadequate glycaemic control on basal insulin: addition of once-weekly tirzepatide versus addition of prandial insulin lispro. Randomisation was stratified by country, baseline glycated haemoglobin level and metformin use. PROs were measured using the Short Form-36 Health Survey version 2 (SF-36v2) acute form (secondary outcome), EQ-5D-5L, Ability to Perform Physical Activities of Daily Living (APPADL) questionnaire and Impact of Weight on Self-Perceptions (IW-SP) questionnaire (tertiary/exploratory outcomes). PROs were compared for the tirzepatide-pooled dose group (5, 10 and 15 mg) and each tirzepatide dose group versus insulin lispro at 52 weeks using the modified intention-to-treat efficacy analysis set. RESULTS Between 19 October 2020 and 01 November 2022, 2267 people were assessed and 1428 participants with T2D were randomised. At 52 weeks, participants in the tirzepatide-pooled group had statistically significant improved scores across all SF-36v2 domains and both component summary scores compared with insulin lispro-treated participants (p < 0.05), with the largest differences observed in the general health, vitality and mental health domains. Statistically significant improved APPADL and IW-SP total scores, as well as EQ visual analogue scale and EQ-5D-5L index scores (after adjustment for baseline scores), were observed in tirzepatide-pooled participants compared with insulin lispro-treated participants. CONCLUSIONS In adult patients with T2D and inadequate glycaemic control with basal insulin, tirzepatide treatment was associated with greater improvements in HRQoL than prandial insulin therapy in addition to clinically significant improvements in glycaemic and body weight-related parameters.
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Affiliation(s)
- Kristina Secnik Boye
- Eli Lilly and Company, Indianapolis, IN, USA.
- Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
| | | | | | | | - Ruth Huh
- Eli Lilly and Company, Indianapolis, IN, USA
| | | | | | - Hiren Patel
- Eli Lilly and Company, Indianapolis, IN, USA
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Emad-Eldin M, Balata GF, Elshorbagy EA, Hamed MS, Attia MS. Insulin therapy in type 2 diabetes: Insights into clinical efficacy, patient-reported outcomes, and adherence challenges. World J Diabetes 2024; 15:828-852. [PMID: 38766443 PMCID: PMC11099362 DOI: 10.4239/wjd.v15.i5.828] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/25/2023] [Revised: 02/01/2024] [Accepted: 03/20/2024] [Indexed: 05/10/2024] Open
Abstract
Insulin therapy plays a crucial role in the management of type 2 diabetes as the disease progresses. Over the past century, insulin formulations have undergone significant modifications and bioengineering, resulting in a diverse range of available insulin products. These products show distinct pharmacokinetic and pharmacodynamic profiles. Consequently, various insulin regimens have em-erged for the management of type 2 diabetes, including premixed formulations and combinations of basal and bolus insulins. The utilization of different insulin regimens yields disparate clinical outcomes, adverse events, and, notably, patient-reported outcomes (PROs). PROs provide valuable insights from the patient's perspective, serving as a valuable mine of information for enhancing healthcare and informing clinical decisions. Adherence to insulin therapy, a critical patient-reported outcome, significantly affects clinical outcomes and is influenced by multiple factors. This review provides insights into the clinical effectiveness of various insulin preparations, PROs, and factors impacting insulin therapy adherence, with the aim of enhancing healthcare practices and informing clinical decisions for individuals with type 2 diabetes.
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Affiliation(s)
- Mahmoud Emad-Eldin
- Department of Pharmacy Practice, Faculty of Pharmacy, Zagazig University, Zagazig HFQM+872, Al-Sharqia Governorate, Egypt
| | - Gehan F Balata
- Department of Pharmacy Practice, Faculty of Pharmacy, Heliopolis University, Cairo 44519, Egypt
- Department of Pharmaceutics, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Eman A Elshorbagy
- Department of Internal Medicine, Faculty of Medicine, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Mona S Hamed
- Department of Community at Faculty of Medicine, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
| | - Mohamed S Attia
- Department of Pharmaceutics, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Al-Sharqia Governorate, Egypt
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Skriver LKL, Nielsen MW, Walther S, Nørlev JD, Hangaard S. Factors associated with adherence or nonadherence to insulin therapy among adults with type 2 diabetes mellitus: A scoping review. J Diabetes Complications 2023; 37:108596. [PMID: 37651772 DOI: 10.1016/j.jdiacomp.2023.108596] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/24/2023] [Accepted: 08/20/2023] [Indexed: 09/02/2023]
Abstract
BACKGROUND AND AIM One of the greatest barriers to the treatment of T2DM is nonadherence which particularly applies to insulin therapy. There is a need for a comprehensive overview of all factors associated with nonadherence to insulin therapy. The aim of this study was to identify factors associated with adherence or nonadherence to insulin therapy among adults with T2DM. METHODS A scoping review was conducted in accordance with the PRISMA 2020 statement. A systematic search was performed in PubMed, Cinahl, and Web of Science (January 2013 to March 2023). RESULTS A final sample of 48 studies was included in the scoping review. The synthesis revealed 30 factors associated with adherence or nonadherence. The factors were grouped into 6 themes: demographics, attitude and perceptions, management of diabetes, impact on daily living, disease and medication, and healthcare system. CONCLUSION The most prominent factors identified were age, cost of healthcare, personal beliefs towards insulin therapy, social stigma, patient education, complexity of diabetes treatment, impact of insulin therapy on daily life, and fear of side effects. The results indicate a need for further research to determine threshold values for the factors associated with adherence or nonadherence.
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Affiliation(s)
| | | | - Simone Walther
- Department of Health Science and Technology, Aalborg University, 9220 Aalborg, Denmark
| | | | - Stine Hangaard
- Department of Health Science and Technology, Aalborg University, 9220 Aalborg, Denmark; Steno Diabetes Center North Jutland, 9000 Aalborg, Denmark
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Lingvay I, Catarig AM, Lawson J, Chubb B, Gorst-Rasmussen A, Evans LM. An Indirect Comparison of Basal Insulin Plus Once-Weekly Semaglutide and Fully Optimised Basal-Bolus Insulin in Type 2 Diabetes. Diabetes Ther 2023; 14:123-137. [PMID: 36434159 PMCID: PMC9880115 DOI: 10.1007/s13300-022-01344-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2021] [Accepted: 11/11/2022] [Indexed: 11/26/2022] Open
Abstract
INTRODUCTION To date, there have been few head-to-head comparisons between semaglutide once-weekly (OW) and short-acting meal-time insulin in participants with type 2 diabetes (T2D) treated with basal insulin and requiring treatment intensification. This indirect comparison evaluated the effects of these regimens on glycated haemoglobin (HbA1c), body weight, hypoglycaemia, and other clinically relevant outcomes. METHODS A post-hoc, unanchored, individual participant data meta-analysis was conducted on the basis of data from single treatment arms in the SUSTAIN 5 and DUAL 7 trials. Semaglutide 0.5 mg OW and 1.0 mg OW plus basal insulin were compared with an optimised (treat-to-target) basal-bolus regimen of insulin glargine and insulin aspart over 26 weeks, using regression adjustment to account for baseline differences between the trials. RESULTS Over 26 weeks, semaglutide 1.0 mg OW plus basal insulin reduced mean HbA1c by significantly more than the basal-bolus regimen (treatment difference: - 0.36%; p = 0.003), while semaglutide 0.5 mg OW plus basal insulin was comparable with basal-bolus insulin (treatment difference: 0.08%, p = 0.53). Both doses of semaglutide were associated with significant weight loss relative to insulin intensification (treatment differences: 6.8-9.4 kg; p < 0.001). At both doses, semaglutide intensification required less basal insulin per day than bolus intensification, and more participants on semaglutide met HbA1c targets of < 7.0% and ≤ 6.5% without hypoglycaemia or weight gain (odds ratio [OR] for < 7.0%, 21.9; OR for ≤ 6.5%, 16.2; both p < 0.001). CONCLUSIONS In T2D uncontrolled by basal insulin, intensification with semaglutide 1.0 mg OW was associated with better glycaemic control, weight loss, and reduced hypoglycaemia versus a basal-bolus regimen, while limiting the treatment burden associated with frequent injections. Clinicians could consider treatment intensification with semaglutide when T2D is uncontrolled by basal insulin, especially when weight management is a priority. Effective glycaemic control coupled with weight management can alleviate the burden of diabetes-associated complications.
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Affiliation(s)
- Ildiko Lingvay
- University of Texas Southwestern Medical Center, Dallas, USA
| | | | | | - Barrie Chubb
- Novo Nordisk Ltd, 3 City Place, Beehive Ring Road, Gatwick, UK.
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Lechleitner M, Roden M, Weitgasser R, Ludvik B, Fasching P, Hoppichler F, Kautzky-Willer A, Schernthaner G, Prager R, Kaser S, Wascher TC. [Injection therapy of diabetes]. Wien Klin Wochenschr 2023; 135:45-52. [PMID: 37101024 PMCID: PMC10133050 DOI: 10.1007/s00508-023-02171-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/22/2023] [Indexed: 04/28/2023]
Abstract
The present article is a recommendation of the Austrian Diabetes Association for the practical use of injection therapy (GLP1-receptor agonists and insulin) in type 2 diabetes.
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Affiliation(s)
- Monika Lechleitner
- Avomed-Arbeitskreis für Vorsorgemedizin und Gesundheitsförderung in Tirol, Innsbruck, Österreich
| | - Michael Roden
- Klinik für Endokrinologie und Diabetologie, Medizinische Fakultät, Heinrich-Heine-Universität, Düsseldorf, Deutschland
- Institut für Klinische Diabetologie, Deutsches Diabetes-Zentrum (DDZ), Leibniz-Zentrum für Diabetesforschung, Düsseldorf, Deutschland
- Deutsches Zentrum für Diabetesforschung (DZD e. V.), München-Neuherberg, Deutschland
| | - Raimund Weitgasser
- Abteilung für Innere Medizin, Privatklinik Wehrle-Diakonissen, Salzburg, Österreich
- Universitätsklinik für Innere Medizin I, LKH Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg, Österreich
| | - Bernhard Ludvik
- Medizinische Abteilung mit Diabetologie, Endokrinologie und Nephrologie, Klinik Landstraße, Wien, Österreich
| | - Peter Fasching
- Medizinische Abteilung für Endokrinologie, Rheumatologie und Akutgeriatrie, Wilhelminenspital der Stadt Wien, Wien, Österreich
| | - Friedrich Hoppichler
- Abteilung für Innere Medizin, Krankenhaus der Barmherzigen Brüder Salzburg, Salzburg, Österreich
| | - Alexandra Kautzky-Willer
- Gender Medicine Unit, Klinische Abteilung für Endokrinologie und Stoffwechsel, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Spitalgasse 23, 1090, Wien, Österreich.
| | - Guntram Schernthaner
- Department of Internal Medicine II, Medizinische Universität Wien, Wien, Österreich
| | - Rudolf Prager
- Stoffwechselzentrum im Rudolfinerhaus, Rudolfinerhaus Privatklinik, Wien, Österreich
| | - Susanne Kaser
- Department für Innere Medizin 1, Medizinische Universität Innsbruck, Innsbruck, Österreich
| | - T C Wascher
- Medizinische Abteilung, Hanusch-Krankenhaus, Wien, Österreich
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Mehta R, Billings LK, Liebl A, Vilsbøll T. Transitioning from basal-bolus or premix insulin therapy to a combination of basal insulin and glucagon-like peptide-1 receptor agonist in people with type 2 diabetes. Diabet Med 2022; 39:e14901. [PMID: 35708737 PMCID: PMC9542161 DOI: 10.1111/dme.14901] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2021] [Revised: 04/29/2022] [Accepted: 06/14/2022] [Indexed: 11/27/2022]
Abstract
AIMS Two fixed-ratio combinations (FRCs) of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1RA) are available for once-daily use in adults with type 2 diabetes. We aimed to review the clinical evidence for the efficacy and safety of changing treatment from a basal-bolus insulin (BBI) regimen or a premix insulin to these combination treatments (fixed-ratio or loose) and provide expert opinion on the practicalities of making such a change. METHODS Relevant clinical and trial evidence and general review articles were identified through a literature review of ProQuest (comprising BIOSIS Previews®, Current Contents® Search, Embase® and MEDLINE®) for articles published between 2009 and 2021. RESULTS We identified nine articles reporting the results of FRCs, and seven articles reporting results of loose combinations of basal insulin and GLP-1RAs, in people who transitioned treatment from BBI or premix regimens. In most trials, combination treatment led to improved or equivalent glycaemic control, and a reduction in body weight or BMI, versus the original regimens. Some trials reported a reduction in total insulin dose. A few trials reported reduced or unchanged hypoglycaemia rates, or increased patient satisfaction, with combination therapy where these endpoints were examined. We provide guidance on transitioning of treatment and the patient types most likely to benefit. CONCLUSIONS In people not achieving glycaemic control with BBI or premix insulin regimens, an FRC or loose combination of basal insulin and GLP-1RA may improve control, decrease the risk of body weight gain or hypoglycaemia and reduce the complexity of treatment.
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Affiliation(s)
- Roopa Mehta
- Unidad de Investigación en Enfermedades Metabólicas, Departamento de Endocrinología y MetabolismoInstituto Nacional de Ciencias Médicas y Nutrición Salvador ZubiránMexico CityMexico
| | - Liana K. Billings
- Division of Endocrinology and MetabolismNorthShore University HealthSystemSkokieIllinoisUSA
- Department of MedicineUniversity of Chicago Pritzker School of MedicineSkokieIllinoisUSA
| | - Andreas Liebl
- Center for Diabetes and Metabolism, m&i‐FachklinikBad HeilbrunnGermany
| | - Tina Vilsbøll
- Steno Diabetes Center Copenhagen, Gentofte HospitalGentofteDenmark
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Kheniser K, Aminian A, Kashyap SR. Effects of Metabolic Medicine and Metabolic Surgery on Patient-Reported Outcomes Among Patients with Type 2 Diabetes. Metab Syndr Relat Disord 2022; 20:497-508. [PMID: 35881869 DOI: 10.1089/met.2022.0039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Abstract
The assessment and management of patient-reported outcomes (PROs) is considered secondary to that of cardiometabolic outcomes. When assessed, health-related quality of life (HRQOL), a PRO, can yield pertinent information that cannot be obtained from cardiometabolic assessments. For instance, physical and mental distress can be quantified and treated. Moreover, treatment convenience and satisfaction can be gaged. Behavioral modification, bariatric surgery, and pharmacotherapy can improve PROs. Typically, HRQOL is responsive to changes in weight. Specifically, weight loss and weight gain are associated with positive and negative changes in quality of life, respectively. In addition, patient satisfaction can be influenced by glycemic control. Therefore, hypoglycemia and hyperglycemic episodes can negatively affect patient satisfaction. When managing type 2 diabetes (T2D), it is important to consider how therapies impact PROs. Generally, changes in clinical outcomes mirror changes in PROs. To best manage T2D, integrating the assessment of PROs with clinical outcomes is needed.
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Affiliation(s)
- Karim Kheniser
- Department of General Surgery, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Ali Aminian
- Department of General Surgery, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Sangeeta R Kashyap
- Department of Endocrinology and Metabolism, Cleveland Clinic, Cleveland, Ohio, USA
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Meade LT, Battise D. Evaluation of Clinical Outcomes With the V-Go Wearable Insulin Delivery Device in Patients With Type 2 Diabetes. Clin Diabetes 2021; 39:297-303. [PMID: 34421206 PMCID: PMC8329021 DOI: 10.2337/cd20-0094] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
Uncontrolled type 2 diabetes can lead to a multitude of health complications. Insulin therapy is recommended when patients are unable to reach their A1C goal with oral or noninsulin injectable diabetes medications. This study evaluated the clinical benefits of switching from multiple daily insulin injections to a wearable insulin delivery device (V-Go). A retrospective chart review was conducted on 44 patients who received prescriptions for the V-Go at two family medicine offices. Investigators found a significant reduction in A1C and daily insulin requirements with no impact on weight or BMI.
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Affiliation(s)
- Lisa T. Meade
- Wingate University, Hickory, NC
- Catawba Valley Health System, Hickory, NC
| | - Dawn Battise
- Wingate University, Hickory, NC
- Cabarrus Family Medicine–Harrisburg, Wingate, NC
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A Japanese Study Assessing Glycemic Control with Use of IDegAsp Co-formulation in Patients with Type 2 Diabetes in Clinical Practice: The JAGUAR Study. Adv Ther 2021; 38:1638-1649. [PMID: 33560496 PMCID: PMC7932946 DOI: 10.1007/s12325-021-01623-y] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/12/2020] [Accepted: 01/12/2021] [Indexed: 12/18/2022]
Abstract
Introduction The aim of this study was to evaluate the glycemic control and safety of insulin degludec/insulin aspart (IDegAsp) co-formulation in Japanese patients with type 2 diabetes (T2D) in a real-world clinical setting, including elderly patients (aged > 75 years). Methods Patients (≥ 18 years) diagnosed with T2D, previously treated with insulin were included from the Japanese Medical Data Vision database. Baseline data were taken at the index date, defined as the first IDegAsp prescription claim. Change in glycated hemoglobin (HbA1c) at 12 months was estimated using a mixed model repeated measures analysis. The proportion of patients achieving target HbA1c < 8.0% without experiencing hypoglycemia (identified by International Classification of Disease codes) was calculated at 12 months (365 ± 90 days) after baseline. Results Overall, 10,798 patients were included, 3940 were aged > 75 years, and 913 had baseline HbA1c values available. Switching to IDegAsp was associated with significantly improved HbA1c values at 12 months (− 1.23% [− 1.43, − 1.02]95%CI, p < 0.001) versus baseline. Moreover, relative to baseline, a significantly greater proportion of patients achieved HbA1c < 8.0% without hypoglycemia at 12 months, relative rate (RR) 1.30 [1.15, 1.45]95%CI, p < 0.001. Results were similar for patients aged ≤ 75 years and aged > 75 years; 66% and 64% of patients, respectively, achieved HbA1c < 8.0% without hypoglycemia at 12 months. Conclusion Switching from insulin to IDegAsp co-formulation was associated with significantly improved glycemic control and a reduction in hypoglycemia rate during 12 months of follow-up in Japanese patients with T2D, including those aged > 75 years. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01623-y.
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Harris S, Abrahamson MJ, Ceriello A, Charpentier G, Evans M, Lehmann R, Liebl A, Linjawi S, Holt RIG, Hosszúfalusi N, Rutten G, Vilsbøll T. Clinical Considerations When Initiating and Titrating Insulin Degludec/Liraglutide (IDegLira) in People with Type 2 Diabetes. Drugs 2020; 80:147-165. [PMID: 31960258 PMCID: PMC7007423 DOI: 10.1007/s40265-019-01245-3] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Therapeutic inertia is a substantial obstacle to the initiation of insulin therapy in people with uncontrolled type 2 diabetes (T2D). This effect has in part been perpetuated by concerns over the impact of a burdensome regimen and the increased risk of hypoglycemia and body weight gain often associated with insulin use. An effective, yet simple, less burdensome regimen with a lower risk of body weight gain and hypoglycemia compared with an insulin-only regimen, may help to address these concerns more effectively. We review the available clinical and real-world data on IDegLira, a once-daily, injectable, fixed-ratio combination of insulin degludec (degludec) and the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide, in people with T2D. Evidence from the comprehensive DUAL clinical trial program suggests an advantage of IDegLira over traditional insulin therapies in a number of clinical outcomes, including maintenance of glycemic control, achievement of glycemic targets, reducing the risk of hypoglycemia, and body weight loss. These findings were demonstrated in participants with T2D irrespective of prior GLP-1RA and insulin use. Furthermore, the individual components of IDegLira have confirmed safety (degludec) or significant benefit in terms of improvement of cardiovascular risk (liraglutide). As an injectable therapy that is simple to titrate, IDegLira has the potential to optimize the ability to achieve relevant glycemic targets, and offers a suitable treatment option for people with T2D requiring insulin therapy who are at risk of hypoglycemia or weight gain.
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Affiliation(s)
- Stewart Harris
- Centre for Studies in Family Medicine, Schulich School of Medicine and Dentistry, Western University, WCPHFM, 1151 Richmond St, London, ON, N6K 3K7, Canada.
| | - Martin J Abrahamson
- Division of Endocrinology, Harvard Medical School, Beth Israel Deaconess Medical Center, 110 Francis Street, Lowry 6A, Boston, MA, 02215, USA
| | - Antonio Ceriello
- IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni, MI, Italy
| | - Guillaume Charpentier
- CERITD (Centre d'Etude et de Recherche pour l'Intensification du Traitement du Diabete), Centre Hospitalier Sud Francilien, 1 Rue Pierre Fontaine, 9100, Corbeil-Essonnes, Evry, France
| | - Marc Evans
- Diabetes Resource Centre, University Hospital Llandough, Penlan Road, Llandough, Cardiff, CF64 2XX, UK
| | - Roger Lehmann
- Department of Endocrinology, Diabetology and Clinical Nutrition, University Hospital of Zürich, Rämistrasse 100 (Arrival), 8091, Zürich, Switzerland
| | - Andreas Liebl
- Center for Diabetes and Metabolism, m&i-Fachklinik, Woernerweg 30, 83670, Bad Heilbrunn, Germany
| | - Sultan Linjawi
- Coffs Diabetes Centre, 9 Murdock Street, Coffs Harbour, NSW, 2450, Australia
| | - Richard I G Holt
- Human Development and Health, University of Southampton Faculty of Medicine, Southampton, UK
| | - Nóra Hosszúfalusi
- 3rd Department of Medicine, Semmelweis University, Kútvölgyi út 4, Budapest, 1125, Hungary
| | - Guy Rutten
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands
| | - Tina Vilsbøll
- Steno Diabetes Center Copenhagen, Gentofte Hospital, University of Copenhagen, Kildegaards Vej 28, 2900, Hellerup, Denmark
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Gaweł WB, Deja G, Kamińska H, Tabor A, Skała-Zamorowska E, Jarosz-Chobot P. How does a predictive low glucose suspend (PLGS) system tackle pediatric lifespan challenges in diabetes treatment? Real world data analysis. Pediatr Diabetes 2020; 21:280-287. [PMID: 31715059 DOI: 10.1111/pedi.12944] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2019] [Revised: 09/17/2019] [Accepted: 10/28/2019] [Indexed: 12/26/2022] Open
Abstract
OBJECTIVES The aim of the study was to assess the benefits of a predictive low glucose suspend (PLGS) system in real-life in children and adolescents with type 1 diabetes of different age and age-related clinical challenges. METHODS Real life retrospective and descriptive analysis included 44 children (26 girls) with type 1 diabetes who were introduced to PLGS system. We divided them in three age groups: I (3-6 years old, n = 12), II (7-10 y/o, n = 16), III (11-19 y/o, n = 16). All children and their caregivers received unified training in self-management during PLGS therapy. Patients' data included: age, HbA1C levels, sex. While from the CGM metric, we obtained: time of sensor use (SENSuse), time in range (TiR): in, below and over target range and average blood glycemia (AVG), insulin suspension time (INSsusp). RESULTS SENSuse was 93% in total, with 92%, 94%, and 87% in age groups I, II, III, respectively. In total the reduction of mean HbA1C from 7.61% to 6.88% (P < .05), while for the I, II, and III it was 7.46% to 6.72%, 6.91% to 6.41%, and 8.46 to 7.44%, respectively (P < .05). Although we observed a significant reduction of HbA1C, the time below target range was minimal. Specific findings included: group I-longest INSsusp (17%), group II-lowest glycemic variability (CV) (36%), and group III-highest AVG (169 mg/dL). There was a reverse correlation between suspend before low and age (-0.32, P < .05). In group I CV reduced TiR in target range (TiRin) (-0.82, P < .05), in group II use of complex boluses increased TiRin (0.52, P < .05). In group III higher CV increased HbA1C (0.64, P < .05) while reducing TiRin (-0.72, P < .05). CONCLUSIONS PLGS is a suitable and safe therapeutic option for children with diabetes of all age and it is effective in addressing age-specific challenges. PLGS improves glycemic control in children of all age, positively affecting its different parameters.
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Affiliation(s)
- Władysław B Gaweł
- Students' Scientific Association at the Department of Children's Diabetology, Medical University of Silesia, Katowice, Poland
| | - Grażyna Deja
- Department of Children's Diabetology, Medical University of Silesia, Katowice, Poland
| | - Halla Kamińska
- Department of Children's Diabetology, Medical University of Silesia, Katowice, Poland
| | - Aleksandra Tabor
- Students' Scientific Association at the Department of Children's Diabetology, Medical University of Silesia, Katowice, Poland
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Patel S, Abreu M, Tumyan A, Adams-Huet B, Li X, Lingvay I. Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study. BMJ Open Diabetes Res Care 2019; 7:e000761. [PMID: 31803482 PMCID: PMC6887507 DOI: 10.1136/bmjdrc-2019-000761] [Citation(s) in RCA: 30] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2019] [Revised: 09/28/2019] [Accepted: 10/23/2019] [Indexed: 12/29/2022] Open
Abstract
Objective Medication adherence is impacted by regimen complexity. The SIMPLE (Simple basal Insulin titration, Metformin Plus Liraglutide for type 2 diabetes with very Elevated HbA1c) study compared GLP1RA plus basal insulin (GLP1RA+BI) to basal-bolus insulin (BBI) regimen in participants with very uncontrolled type 2 diabetes mellitus (T2DM). This analysis aimed to evaluate medication adherence to GLP1RA+BI compared with BBI, the effect of adherence on clinical and patient-reported outcomes, and baseline predictors of adherence. Research design and methods This was an analysis of the SIMPLE study based on prespecified outcome. The study took place in pragmatic, real-world setting. A total of 120 adults with T2DM and HgbA1c≥10% were randomized to detemir plus liraglutide, or detemir plus aspart before each meal; 6-month follow-up. The main outcomes evaluated were: adherence, HgbA1c, weight, quality of life, and hypoglycemia. Adherence rate was calculated for each study medication at each follow-up visit; participants were classified as ≥80% or <80% adherent. Result A higher percentage of participants in the GLP1RA+BI compared with the BBI group had ≥80% adherence to detemir (59.3% vs 35.7%, p=0.02) as well as liraglutide versus aspart (57.4% vs 30.4%, p=0.007). Higher age was predictive of ≥80% adherence (OR per 5-year increment=1.48, 95% CI 1.09 to 2.0, p=0.01). Higher adherence led to greater improvement in HbA1c and weight in both groups. Treatment with GLP1RA+BI compared with BBI led to greater improvement in HbA1c, weight, and quality of life and lower risk of hypoglycemia even after adjusting for the difference in adherence between groups. Conclusions Adherence was higher with the simplified regimen of GLP1RA+BI compared with BBI. Greater adherence to the simpler regimen amplified the treatment effect on HbA1c, weight, quality of life, and risk of hypoglycemia, yet statistically significant greater benefits were noted even when adjusted for adherence. Trial registration number NCT01966978.
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Affiliation(s)
- Sapna Patel
- Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA
| | - Marconi Abreu
- Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA
| | - Anna Tumyan
- Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA
| | - Beverley Adams-Huet
- Population and Data Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA
| | - Xilong Li
- Population and Data Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA
| | - Ildiko Lingvay
- Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA
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Lechleitner M, Clodi M, Abrahamian H, Brath H, Brix J, Drexel H, Fasching P, Föger B, Francesconi C, Fröhlich-Reiterer E, Harreiter J, Hofer SE, Hoppichler F, Huber J, Kaser S, Kautzky-Willer A, Ludvik B, Luger A, Mader JK, Paulweber B, Pieber T, Prager R, Rami-Merhar B, Resl M, Riedl M, Roden M, Saely CH, Schelkshorn C, Schernthaner G, Sourij H, Stechemesser L, Stingl H, Toplak H, Wascher TC, Weitgasser R, Winhofer-Stöckl Y, Zlamal-Fortunat S. [Insulin therapy of type 2 diabetes mellitus (Update 2019)]. Wien Klin Wochenschr 2019; 131:39-46. [PMID: 30980147 DOI: 10.1007/s00508-019-1492-7] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
The present article is a recommendation of the Austrian Diabetes Association for the practical use of insulin in type 2 diabetes, including the various insulin regimens.
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Affiliation(s)
- Monika Lechleitner
- Interne Abteilung, Landeskrankenhaus Hochzirl - Natters, Hochzirl, 6170, Zirl, Österreich.
| | - Martin Clodi
- ICMR - Institute for Cardiovascular and Metabolic Research, Johannes Kepler Universität Linz, Linz, Österreich.,Abteilung für Innere Medizin, Konventhospital der Barmherzigen Brüder Linz, Linz, Österreich
| | | | - Helmut Brath
- Diabetes Ambulanz, Gesundheitszentrum Wien-Süd, Wien, Österreich
| | - Johanna Brix
- 1. Medizinische Abteilung mit Diabetologie, Endokrinologie und Nephrologie, Krankenanstalt Rudolfstiftung, Wien, Österreich
| | - Heinz Drexel
- Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Österreich.,Private Universität im Fürstentum Liechtenstein, Triesen, Liechtenstein.,Drexel University College of Medicine, Philadelphia, PA, USA.,Abteilung für Angiologie, Universitätsspital Bern, Bern, Schweiz.,Chair der ESC-Working Group "Cardiovascular Pharmacotherapy", Sophia Antipolis, Frankreich
| | - Peter Fasching
- 5. Medizinische Abteilung für Endokrinologie, Rheumatologie und Akutgeriatrie, Wilhelminenspital der Stadt Wien, Wien, Österreich
| | - Bernhard Föger
- Interne Abteilung, Landeskrankenhaus Bregenz, Bregenz, Österreich.,AKS Gesundheit, Bregenz, Österreich
| | | | - Elke Fröhlich-Reiterer
- Universitätsklinik für Kinder- und Jugendheilkunde, Medizinische Universität Graz, Graz, Österreich
| | - Jürgen Harreiter
- Klinische Abteilung für Endokrinologie und Stoffwechsel, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Wien, Österreich
| | - Sabine E Hofer
- Department für Pädiatrie 1, Medizinische Universität Innsbruck, Innsbruck, Österreich
| | - Friedrich Hoppichler
- Abteilung für Innere Medizin, Krankenhaus der Barmherzigen Brüder Salzburg, Salzburg, Österreich
| | - Joakim Huber
- Interne Abteilung mit Akutgeriatrie und Palliativmedizin, Franziskus Spital, Standort Landstraße, Wien, Österreich
| | - Susanne Kaser
- Department für Innere Medizin I, Medizinische Universität Innsbruck, Innsbruck, Österreich.,Christian Doppler Labor für Insulinresistenz, Medizinische Universität Innsbruck, Innsbruck, Österreich
| | - Alexandra Kautzky-Willer
- Gender Medicine Unit, Klinische Abteilung für Endokrinologie und Stoffwechsel, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Wien, Österreich
| | - Bernhard Ludvik
- 1. Medizinische Abteilung mit Diabetologie, Endokrinologie und Nephrologie, Krankenanstalt Rudolfstiftung, Wien, Österreich
| | - Anton Luger
- Klinische Abteilung für Endokrinologie und Stoffwechsel, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Wien, Österreich
| | - Julia K Mader
- Klinische Abteilung für Endokrinologie und Diabetologie, Universitätsklinik für Innere Medizin, Medizinische Universität Graz, Graz, Österreich
| | - Bernhard Paulweber
- Universitätsklinik für Innere Medizin I, mit Gastroenterologie, Hepatologie, Nephrologie, Stoffwechsel und Diabetologie, Paracelsus Medizinische Privatuniversität, Salzburg, Österreich
| | - Thomas Pieber
- Universitätsklinik für Innere Medizin, Medizinische Universität Graz, Graz, Österreich
| | - Rudolf Prager
- 3. Medizinische Abteilung mit Stoffwechselerkrankungen und Nephrologie, Krankenhaus Hietzing, Wien, Österreich
| | - Birgit Rami-Merhar
- Universitätsklinik für Kinder- und Jugendheilkunde, Medizinische Universität Wien, Wien, Österreich
| | - Michael Resl
- Abteilung für Innere Medizin, Konventhospital der Barmherzigen Brüder Linz, Linz, Österreich
| | - Michaela Riedl
- Klinische Abteilung für Endokrinologie und Stoffwechsel, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Wien, Österreich
| | - Michael Roden
- Klinik für Endokrinologie und Diabetologie, Medizinische Fakultät, Heinrich-Heine-Universität, Düsseldorf, Deutschland.,Institut für Klinische Diabetologie, Deutsches Diabetes-Zentrum (DDZ), Leibniz-Zentrum für Diabetesforschung, Düsseldorf, Deutschland.,Deutsches Zentrum für Diabetesforschung, DZD e. V., München-Neuherberg, Deutschland
| | - Christoph H Saely
- Abteilung für Innere Medizin I, Akademisches Lehrkrankenhaus Feldkirch, Feldkirch, Österreich
| | | | - Guntram Schernthaner
- 1. Medizinische Abteilung mit Diabetologie, Endokrinologie und Department für Nephrologie, Krankenanstalt Rudolfstiftung, Wien, Österreich
| | - Harald Sourij
- Klinische Abteilung für Endokrinologie und Diabetologie, Universitätsklinik für Innere Medizin, Medizinische Universität Graz, Graz, Österreich
| | - Lars Stechemesser
- Universitätsklinik für Innere Medizin I, mit Gastroenterologie, Hepatologie, Nephrologie, Stoffwechsel und Diabetologie, Paracelsus Medizinische Privatuniversität, Salzburg, Österreich
| | - Harald Stingl
- Abteilung für Innere Medizin, Landesklinikum Melk, Melk, Österreich
| | - Hermann Toplak
- Klinische Abteilung für Endokrinologie und Diabetologie, Universitätsklinik für Innere Medizin, Medizinische Universität Graz, Graz, Österreich
| | - Thomas C Wascher
- 1. Medizinische Abteilung, Hanusch-Krankenhaus, Wien, Österreich
| | - Raimund Weitgasser
- Abteilung für Innere Medizin, Privatklinik Wehrle-Diakonissen, Salzburg, Österreich.,Universitätsklinik für Innere Medizin I, LKH Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg, Österreich
| | - Yvonne Winhofer-Stöckl
- Klinische Abteilung für Endokrinologie und Stoffwechsel, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Wien, Österreich
| | - Sandra Zlamal-Fortunat
- Abteilung für Innere Medizin und Gastroenterologie, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Österreich
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Brod M, Basse A, Markert M, Pfeiffer KM. Post-Basal Insulin Intensification and Healthcare Resource Use in Type 2 Diabetes: A Web-Based Physician Survey in the United States and United Kingdom. Diabetes Ther 2019; 10:1323-1336. [PMID: 31127490 PMCID: PMC6612333 DOI: 10.1007/s13300-019-0636-0] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2019] [Indexed: 01/19/2023] Open
Abstract
INTRODUCTION Currently, there is limited knowledge of the healthcare resources and time needed to intensify patients with type 2 diabetes (T2D) treated with basal insulin to more complex treatment regimens. The purpose of the study was to investigate physicians' perspectives on the time and healthcare resources required for post-basal insulin intensification to basal-bolus and to basal in combination with a glucagon-like peptide-1 receptor agonist (GLP-1) regimens. The study also examined referrals to specialists for intensification and patient challenges with intensification. METHODS A web-based survey of physicians was conducted in the United Kingdom (UK) and the United States (USA). RESULTS A total of 458 physicians completed the survey, including general practitioners (58.5%) and specialists (endocrinologists/diabetologists; 41.5%). On average, 7.0 healthcare provider (HCP) visits (SD 3.7) over 30.1 weeks (SD 17.4) were required to intensify to a basal-bolus regimen, while 5.7 HCP visits (SD 3.8) over 23.5 weeks (SD 15.2) were needed to intensify to basal insulin in combination with GLP-1. Referral to a specialist for intensification required on average an additional 8 weeks of wait time before intensification. Physicians reported that the complexity of the basal-bolus regimen and frequent injections were key challenges for T2D patients intensifying to basal-bolus, while frequent injections and side effects were key challenges for those intensifying with GLP-1. CONCLUSION Less complex regimens for intensification following basal insulin may help reduce the time and healthcare resources required for intensification and address some of the challenges T2D patients face when intensifying to basal-bolus or basal with GLP-1. FUNDING Novo Nordisk, A/S.
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Affiliation(s)
- Meryl Brod
- The Brod Group, 219 Julia Avenue, Mill Valley, CA, 94941, USA.
| | - Amaury Basse
- Novo Nordisk A/S, Vandtaarnsvej 114, 2860, Soeborg, Denmark
| | - Marie Markert
- Novo Nordisk A/S, Vandtaarnsvej 114, 2860, Soeborg, Denmark
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