A Randomized Controlled Trial Comparing the Efficacy and Safety of IDegLira Versus Basal-Bolus in Patients With Poorly Controlled Type 2 Diabetes and Very High HbA1c ≥9-15%: DUAL HIGH Trial
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Details
- Title
- A Randomized Controlled Trial Comparing the Efficacy and Safety of IDegLira Versus Basal-Bolus in Patients With Poorly Controlled Type 2 Diabetes and Very High HbA1c ≥9-15%: DUAL HIGH Trial
- Creators
- Rodolfo J GalindoBobak MoazzamiMaria F SciosciaCesar ZambranoBonnie S AlburyJarrod SalingPriyathama VellankiFrancisco J PasquelGeorgia M DavisMaya FayfmanLimin PengGuillermo E Umpierrez
- Publication Details
- Diabetes care
- Grant note
- Prior Presentation. Parts of this study were presented as oral presentation at the 82nd Scientific Sessions of the American Diabetes Association, virtual and at New Orleans, LA, 3-7 June 2022.American Diabetes Association
Acknowledgments. The authors extend personal thanks to Professor Clare Bradley, Health Psychology Research, Royal Holloway University of London, Surrey, U.K., for granting permission to use the Diabetes Treatment Satisfaction Questionnaire (DTSQ) questionnaire.r Funding. R.J.G. is supported in part by grants from the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under award numbers P30DK111024-04S2 and 1K23DK123384-03. P.V. is supported in part by NIH/NIDDK grant 1K23DK113241. F.J.P. is supported in part by NIH National Institute of General Medical Sciences under award number K23GM12822103 and NIH/NIDDK P30DK111024 and P30DK11102405S1. G.E.U. is partly supported by NIH National Center for Advancing Translational Sciences Award program research grant 3UL1TR002378-05S2, and from NIH/NIDDK (2P30DK111024-06) and National Center for Research Resources.r Duality of Interest. This study was an investigator-initiated clinical trial funded by a grant from Novo Nordisk (IIS to Emory University). A contract was developed between Novo Nordisk and Emory University (primary investigator: R.J.G.), which became the academic sponsor of the study. R.J.G. received unrestricted research support (to Emory University) from Novo Nordisk, Eli Lilly and Dexcom Inc., and consulting fees from Sanofi, Novo Nordisk, Eli Lilly, Pfizer, Boehringer, Bayer, and Weight Watchers. P.V. has received consulting fees from Merck and Boehringer-Ingelheim. F.J.P. has received consulting fees from Merck, Boehringer-Ingelheim, Eli Lilly, and Medscape, and research support from Merck, Ideal Medical Technologies, Insulet, and Dexcom Inc. G.M.D. and has received research support from Insulet and consulting fees from Medscape. M.F. receives research support from Dexcom Inc. G.E.U. has received research support (to Emory University) from Bayer, Abbott, and Dexcom.r The funder of the study had no role in study design, data analysis, and interpretation, or writing of the report.r Author Contributions. R.J.G. wrote the initial research proposal and critically reviewed research data and wrote the initial manuscript. B.M., M.F.S., C.Z., B.S.A., and J.S. screened, consented, and followed participants in the study, reviewed the data and analysis, and edited the manuscript. P.V., F.J.P., G.M.D., M.F., and G.E.U. reviewed the initial research proposal, conducted the study, reviewed the data and analysis, and edited the manuscript. L.P. generated the random allocation sequence and performed the statistical analysis. R.J.G. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.r Prior Presentation. Parts of this study were presented as oral presentation at the 82nd Scientific Sessions of the American Diabetes Association, virtual and at New Orleans, LA, 3-7 June 2022.
- Academic Unit
- Miller School of Medicine; UMMG Department of Medicine
- Language
- English
- Resource Type
- Journal article
- PMID
- 37459574
- Record Identifier
- 991031911306402976