Differential Effects of Type 2 Diabetes Treatment Regimens on Diabetes Distress and Depressive Symptoms in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)
Author:
Gonzalez Jeffrey S.1234ORCID, Bebu Ionut5ORCID, Krause-Steinrauf Heidi5ORCID, Hoogendoorn Claire J.12ORCID, Crespo-Ramos Gladys12, Presley Caroline6ORCID, Naik Aanand D.7ORCID, Kuo Shihchen8ORCID, Johnson Mary L.9, Wexler Deborah10ORCID, Crandall Jill P.2, Bantle Anne E.11, Arends Valerie12, Cherrington Andrea L.13ORCID, , 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. 1Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY 2. 2Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY 3. 3Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, NY 4. 4New York-Regional Center for Diabetes Translation Research, Albert Einstein College of Medicine, Bronx, New York, NY 5. 5The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD 6. 6Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL 7. 7School of Public Health, University of Texas Health Science Center, Houston, TX 8. 8Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI 9. 9International Diabetes Center, Minneapolis, MN 10. 10Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 11. 11Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Minnesota, Minneapolis, MN 12. 12Advanced Research and Diagnostic Laboratory, Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN 13. 13Department of Medicine (General Internal and Preventive Medicine), University of Alabama at Birmingham, Birmingham, AL
Abstract
OBJECTIVE
We evaluated whether adding basal insulin to metformin in adults with early type 2 diabetes mellitus (T2DM) would increase emotional distress relative to other treatments.
RESEARCH DESIGN AND METHODS
The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years’ duration, HbA1c 6.8–8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up.
RESULTS
Across treatments, diabetes distress (−0.24, P < 0.0001) and depressive symptoms (−0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (−0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (−0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms.
CONCLUSIONS
Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM.
Funder
Centers for Disease Control and Prevention National Heart, Lung, and Blood Institute American Diabetes Association National Institute of Diabetes and Digestive and Kidney Diseases
Publisher
American Diabetes Association
Cited by
4 articles.
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