Association of Baseline Factors With Glycemic Outcomes in GRADE: A Comparative Effectiveness Randomized Clinical Trial
Author:
Garvey W. Timothy1ORCID, Cohen Robert M.2, Butera Nicole M.3, Kazemi Erin J.3, Younes Naji3ORCID, Rosin Samuel P.3, Suratt Colleen E.3ORCID, Ahmann Andrew4ORCID, Hollander Priscilla A.5ORCID, Krakoff Jonathan6, Martin Catherine L.7, Seaquist Elizabeth8ORCID, Steffes Michael W.9, Lachin John M.3ORCID, , Crandall J.P., McKee M.D., Behringer-Massera S., Brown-Friday J., Xhori E., Ballentine-Cargill K., Duran S., Estrella H., Gonzalez de la torre S., Lukin J., Phillips L.S., Burgess E., Olson D., Rhee M., Wilson P., Raines T.S., Boers J., Costello J., Maher-Albertelli M., Mungara R., Savoye L., White C.A., Gullett C., Holloway L., Morehead F., Person S., Sibymon M., Tanukonda S., Adams C., Ross A., Balasubramanyam A., Gaba R., Gonzalez Hattery E., Ideozu A., Jimenez J., Montes G., Wright C., Hollander P., Roe E., Jackson A., Smiley A., Burt P., Estrada L., Chionh K., Ismail-Beigi F., Falck-Ytter C., Sayyed Kassem L., Sood A., Tiktin M., Kulow T., Newman C., Stancil K.A., Cramer B., Iacoboni J., Kononets M.V., Sanders C., Tucker L., Werner A., Maxwell A., McPhee G., Patel C., Colosimo L., Krol A., Goland R., Pring J., Alfano L., Kringas P., Hausheer C., Tejada J., Gumpel K., Kirpitch A., Schneier H., Green J.B., AbouAssi H., Chatterjee R., Feinglos M.N., English Jones J., Khan S.A., Kimpel J.B., Zimmer R.P., Furst M., Satterwhite B.M., Thacker C.R., Evans Kreider K., Mariash C.N., Mather K.J., Ismail H.M., Lteif A., Mullen M., Hamilton T., Patel N., Riera G., Jackson M., Pirics V., Aguillar D., Howard D., Hurt S., Bergenstal R., Carlson A., Martens T., Johnson M., Hill R., Hyatt J., Jensen C., Madden M., Martin D., Willis H., Konerza W., Yang S., Kleeberger K., Passi R., Fortmann S., Herson M., Mularski K., Glauber H., Prihoda J., Ash B., Carlson C., Ramey P.A., Schield E., Torgrimson-Ojerio B., Arnold K., Kauffman B., Panos E., Sahnow S., Bays K., Berame K., Cook J., Ghioni D., Gluth J., Schell K., Criscola J., Friason C., Jones S., Nazarov S., Barzilay J., Rassouli N., Puttnam R., Ojoawo B., Nelson R., Curtis M., Hollis B., Sanders-Jones C., Stokes K., El-Haqq Z., Kolli A., Tran T., Wexler D., Larkin M.E., Meigs J., Chambers B., Dushkin A., Rocchio G., Yepes M., Steiner B., Dulin H., Cayford M., Chu K., DeManbey A., Hillard M., Martin K., Thangthaeng N., Gurry L., Kochis R., Raymond E., Ripley V., Stevens C., Park J., Aroda V., Ghazi A., Magee M., Ressing A., Loveland A., Hamm M., Hurtado M., Kuhn A., Leger J., Manandhar L., Mwicigi F., Sanchez O., Young T., Garg R., Lagari-Libhaber V., Florez H.J., Valencia W.M., Marks J., Casula S., Oropesa-Gonzalez L., Hue L., Cuadot A., Nieto-Martinez R., Riccio Veliz A.K., Gutt M., Kendal Y.J., Veciana B., Ahmann A., Aby-Daniel D., Joarder F., Morimoto V., Sprague C., Yamashita D., Cady N., Rivera-Eschright N., Kirchhoff P., Morales Gomez B., Adducci J., Goncharova A., Hox S.H., Petrovitch H., Matwichyna M., Jenkins V., Broadwater L., Ishii R.R., Bermudez N.O., Hsia D.S., Cefalu W.T., Greenway F.L., Waguespack C., King E., Fry G., Dragg A., Gildersleeve B., Arceneaux J., Haynes N., Thomassie A., Pavlionis M., Bourgeois B., Hazlett C., Mudaliar S., Henry R., Boeder S., Pettus J., Diaz E., Garcia-Acosta D., Maggs S., DeLue C., Stallings A., Castro E., Hernandez S., Krakoff J., Curtis J.M., Killean T., Khalid M., Joshevama E., Diaz E., Martin D., Tsingine K., Karshner T., Albu J., Pi-Sunyer F.X., Frances S., Maggio C., Ellis E., Bastawrose J., Gong X., Banerji M.A., August P., Lee M., Lorber D., Brown N.M., Josephson D.H., Thomas L.L., Tsovian M., Cherian A., Jacobson M.H., Mishko M.M., Kirkman M.S., Buse J.B., Diner J., Dostou J., Machineni S., Young L., Bergamo K., Goley A., Kerr J., Largay J.F., Guarda S., Cuffee J., Culmer D., Fraser R., Almeida H., Coffer S., Debnam E., Kiker L., Morton S., Josey K., Fuller G., Garvey W.T., Cherrington A.L., Dyer D., Lawson M.C.R., Griffith O., Agne A., McCullars S., Cohen R.M., Craig J., Rogge M.C., Burton K., Kersey K., Wilson C., Lipp S., Vonder Meulen M.B., Adkins C., Onadeko T., Rasouli N., Baker C., Schroeder E., Razzaghi M., Lyon C., Penaloza R., Underkofler C., Lorch R., Douglass S., Steiner S., Sivitz W.I., Cline E., Knosp L.K., McConnell J., Lowe T., Herman W.H., Pop-Busui R., Tan M.H., Martin C., Waltje A., Katona A., Goodhall L., Eggleston R., Kuo S., Bojescu S., Bule S., Kessler N., LaSalle E., Whitley K., Seaquist E.R., Bantle A., Harindhanavudhi T., Kumar A., Redmon B., Bantle J., Coe M., Mech M., Taddese A., Lesne K., Smith S., Desouza C., Kuechenmeister L., Shivaswamy V., Burbach S., Rodriguez M.G., Seipel K., Alfred A., Morales A.L., Eggert J., Lord G., Taylor W., Tillson R., Schade D.S., Adolphe A., Burge M., Duran-Valdez E., Martinez J., Bancroft A., Kunkel S., Ali Jamaleddin Ahmad F., Hernandez McGinnis D., Pucchetti B., Scripsick E., Zamorano A., DeFronzo R.A., Cersosimo E., Abdul-Ghani M., Triplitt C., Juarez D., Mullen M., Garza R.I., Verastiqui H., Wright K., Puckett C., Raskin P., Rhee C., Abraham S., Jordan L.F., Sao S., Morton L., Smith O., Osornio Walker L., Schnurr-Breen L., Ayala R., Kreymer R.B., Sturgess D., Utzschneider K.M., Kahn S.E., Alarcon-Casas Wright L., Boyko E.J., Tsai E.C., Trence D.L., Trikudanathan S., Fattaleh B.N., Montgomery B.K., Atkinson K.M., Kozedub A., Concepcion T., Moak C., Prikhodko N., Rhothisen S., Elasy T.A., Martin S., Shackelford L., Goidel R., Hinkle N., Lovell C., Myers J., Lipps Hogan J., McGill J.B., Salam M., Schweiger T., Kissel S., Recklein C., Clifton M.J., Tamborlane W., Camp A., Gulanski B., Inzucchi S.E., Pham K., Alguard M., Gatcomb P., Lessard K., Perez M., Iannone L., Magenheimer E., Montosa A., Fradkin J., Burch H.B., Bremer A.A., Nathan D.M., Lachin J.M., Krause-Steinrauf H., Younes N., Bebu I., Butera N., Buys C.J., Fagan A., Gao Y., Ghosh A., Gramzinski M.R., Hall S.D., Kazemi E., Legowski E., Liu H., Suratt C., Tripputi M., Arey A., Backman M., Bethepu J., Lund C., Mangat Dhaliwal P., McGee P., Mesimer E., Ngo L., Steffes M., Seegmiller J., Saenger A., Arends V., Gabrielson D., Conner T., Warren S., Day J., Huminik J., Scrymgeour A., Soliman E.Z., Pokharel Y., Zhang Z.M., Campbell C., Hu J., Keasler L., Hensley S., Li Y., Mihalcea R., Min D.J., Perez-Rosas V., Prosser L., Resnicow L., Ye W., Shao H., Zhang P., Luchsinger J., Sanchez D., Assuras S., Groessl E., Sakha F., Chong H., Hillery N., Abdouch I., Bahtiyar G., Brantley P., Broyles F.E., Canaris G., Copeland P., Craine J.J., Fein W.L., Gliwa A., Hope L., Lee M.S., Meiners R., Meiners V., O’Neal H., Park J.E., Sacerdote A., Sledge E., Soni L., Steppel-Reznik J., Turchin A., Golden S., Gonzalez J., Naik A., Walker E.
Affiliation:
1. 1Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL 2. 2Division of Endocrinology, Diabetes, and Metabolism, University of Cincinnati College of Medicine and Cincinnati VA Medical Center, Cincinnati, OH 3. 3The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD 4. 4Division of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health and Science University, Portland, OR 5. 5Baylor Scott & White Research Institute, Dallas, TX 6. 6Southwestern American Indian Center, Phoenix, AZ 7. 7Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI 8. 8Division of Diabetes and Endocrinology, Department of Medicine, University of Minnesota, Minneapolis, MN 9. 9Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN
Abstract
OBJECTIVE
To describe the individual and joint associations of baseline factors with glycemia, and also with differential effectiveness of medications added to metformin.
RESEARCH DESIGN AND METHODS
Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) participants (with type 2 diabetes diagnosed for <10 years, on metformin, and with HbA1c 6.8–8.5%; N = 5,047) were randomly assigned to a basal insulin (glargine), sulfonylurea (glimepiride), glucagon-like peptide 1 agonist (liraglutide), or dipeptidyl peptidase 4 inhibitor (sitagliptin). The glycemic outcome was HbA1c ≥7.0%, subsequently confirmed. Univariate and multivariate regression and classification and regression tree (CART) analyses were used to assess the association of baseline factors with the glycemic outcome at years 1 and 4.
RESULTS
In univariate analyses at baseline, younger age (<58 years), Hispanic ethnicity, higher HbA1c, fasting glucose, and triglyceride levels, lower insulin secretion, and relatively greater insulin resistance were associated with the glycemic outcome at years 1 and/or 4. No factors were associated with differential effectiveness of the medications by year 4. In multivariate analyses, treatment group, younger age, and higher baseline HbA1c and fasting glucose were jointly associated with the glycemic outcome by year 4. The superiority of glargine and liraglutide at year 4 persisted after multiple baseline factors were controlled for. CART analyses indicated that failure to maintain HbA1c <7% by year 4 was more likely for younger participants and those with baseline HbA1c ≥7.4%.
CONCLUSIONS
Several baseline factors were associated with the glycemic outcome but not with differential effectiveness of the four medications. Failure to maintain HbA1c <7% was largely driven by younger age and higher HbA1c at baseline. Factors that predict earlier glycemic deterioration could help in targeting patients for more aggressive management.
Funder
American Diabetes Association National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases Centers for Disease Control and Prevention
Publisher
American Diabetes Association
Cited by
4 articles.
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