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The Use of Rescue Insulin in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).
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- Author(s): Hollander PA;Hollander PA; Krause-Steinrauf H; Krause-Steinrauf H; Butera NM; Butera NM; Kazemi EJ; Kazemi EJ; Ahmann AJ; Ahmann AJ; Fattaleh BN; Fattaleh BN; Johnson ML; Johnson ML; Killean T; Killean T; Lagari VS; Lagari VS; Larkin ME; Larkin ME; Legowski EA; Legowski EA; Rasouli N; Rasouli N; Willis HJ; Willis HJ; Martin CL; Martin CL
- Source:
Diabetes care [Diabetes Care] 2024 Apr 01; Vol. 47 (4), pp. 638-645.- Publication Type:
Randomized Controlled Trial; Journal Article- Language:
English - Source:
- Additional Information
- Corporate Authors:
- Source: Publisher: American Diabetes Association Country of Publication: United States NLM ID: 7805975 Publication Model: Print Cited Medium: Internet ISSN: 1935-5548 (Electronic) Linking ISSN: 01495992 NLM ISO Abbreviation: Diabetes Care Subsets: MEDLINE
- Publication Information: Publication: Alexandria Va : American Diabetes Association
Original Publication: New York, American Diabetes Assn. - Subject Terms: Diabetes Mellitus, Type 2*/drug therapy ; Metformin*/therapeutic use ; Sulfonylurea Compounds*; Humans ; Insulin/therapeutic use ; Insulin Glargine/therapeutic use ; Hypoglycemic Agents/therapeutic use ; Liraglutide/therapeutic use ; Glycated Hemoglobin ; Blood Glucose ; Sitagliptin Phosphate/therapeutic use ; Insulin, Regular, Human/therapeutic use
- Abstract: Objective: To describe rescue insulin use and associated factors in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).
Research Design and Methods: GRADE participants (type 2 diabetes duration <10 years, baseline A1C 6.8%-8.5% on metformin monotherapy, N = 5,047) were randomly assigned to insulin glargine U-100, glimepiride, liraglutide, or sitagliptin and followed quarterly for a mean of 5 years. Rescue insulin (glargine or aspart) was to be started within 6 weeks of A1C >7.5%, confirmed. Reasons for delaying rescue insulin were reported by staff-completed survey.
Results: Nearly one-half of GRADE participants (N = 2,387 [47.3%]) met the threshold for rescue insulin. Among participants assigned to glimepiride, liraglutide, or sitagliptin, rescue glargine was added by 69% (39% within 6 weeks). Rescue aspart was added by 44% of glargine-assigned participants (19% within 6 weeks) and by 30% of non-glargine-assigned participants (14% within 6 weeks). Higher A1C values were associated with adding rescue insulin. Intention to change health behaviors (diet/lifestyle, adherence to current treatment) and not wanting to take insulin were among the most common reasons reported for not adding rescue insulin within 6 weeks.
Conclusions: Proportionately, rescue glargine, when required, was more often used than rescue aspart, and higher A1C values were associated with greater rescue insulin use. Wanting to use noninsulin strategies to improve glycemia was commonly reported, although multiple factors likely contributed to not using rescue insulin. These findings highlight the persistent challenge of intensifying type 2 diabetes treatment with insulin, even in a clinical trial.
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Diabetes Spectr. 2020 Feb;33(1):38-43. (PMID: 32116452) - Grant Information: UL1 TR000445 United States TR NCATS NIH HHS; U01DK098246 United States DK NIDDK NIH HHS; United States HL NHLBI NIH HHS; UL1 TR002529 United States TR NCATS NIH HHS; UL1 TR002541 United States TR NCATS NIH HHS; UL1 TR000439 United States TR NCATS NIH HHS; P30 DK020541 United States DK NIDDK NIH HHS; UL1 TR002378 United States TR NCATS NIH HHS; P30 DK020572 United States DK NIDDK NIH HHS; UL1 TR002243 United States TR NCATS NIH HHS; UL1 TR002345 United States TR NCATS NIH HHS; UL1 TR002548 United States TR NCATS NIH HHS; U34 DK088043 United States DK NIDDK NIH HHS; UL1 TR002537 United States TR NCATS NIH HHS; P30 DK092926 United States DK NIDDK NIH HHS; UL1 TR002535 United States TR NCATS NIH HHS; P30 DK072476 United States DK NIDDK NIH HHS; P30 DK079626 United States DK NIDDK NIH HHS; UL1 TR001409 United States TR NCATS NIH HHS; U01 DK098246 United States DK NIDDK NIH HHS; UL1 TR001449 United States TR NCATS NIH HHS; UL1 TR002489 United States TR NCATS NIH HHS; U54 GM104940 United States GM NIGMS NIH HHS; UL1 TR001108 United States TR NCATS NIH HHS; UL1 TR001425 United States TR NCATS NIH HHS; UM1 TR004528 United States TR NCATS NIH HHS; UL1 TR000170 United States TR NCATS NIH HHS; UL1 TR001102 United States TR NCATS NIH HHS; P30 DK017047 United States DK NIDDK NIH HHS; United States CC CDC HHS
- Contributed Indexing: Investigator: JP Crandall; MD McKee; S Behringer-Massera; J Brown-Friday; E Xhori; K Ballentine-Cargill; S Duran; H Estrella; S Gonzalez de la Torre; J Lukin; LS Phillips; E Burgess; D Olson; M Rhee; P Wilson; TS Raines; J Boers; J Costello; M Maher-Albertelli; R Mungara; L Savoye; CA White; C Gullett; L Holloway; F Morehead; S Person; M Sibymon; S Tanukonda; C Adams; A Ross; A Balasubramanyam; R Gaba; E Gonzalez Hattery; A Ideozu; J Jimenez; G Montes; C Wright; P Hollander; E Roe; A Jackson; A Smiley; P Burt; L Estrada; K Chionh; F Ismail-Beigi; C Falck-Ytter; L Sayyed Kassem; A Sood; M Tiktin; T Kulow; C Newman; KA Stancil; B Cramer; J Iacoboni; MV Kononets; C Sanders; L Tucker; A Werner; A Maxwell; G McPhee; C Patel; L Colosimo; A Krol; R Goland; J Pring; L Alfano; P Kringas; C Hausheer; J Tejada; K Gumpel; A Kirpitch; H Schneier; JB Green; H AbouAssi; R Chatterjee; MN Feinglos; J English Jones; SA Khan; JB Kimpel; RP Zimmer; M Furst; BM Satterwhite; CR Thacker; K Evans Kreider; CN Mariash; KJ Mather; HM Ismail; A Lteif; T Hamilton; N Patel; G Riera; M Jackson; V Pirics; D Aguillar; D Howard; S Hurt; R Bergenstal; A Carlson; T Martens; M Johnson; R Hill; J Hyatt; C Jensen; M Madden; D Martin; H Willis; W Konerza; S Yang; K Kleeberger; R Passi; S Fortmann; M Herson; K Mularski; H Glauber; J Prihoda; B Ash; C Carlson; PA Ramey; E Schield; B Torgrimson-Ojerio; K Arnold; B Kauffman; E Panos; S Sahnow; K Bays; K Berame; J Cook; D Ghioni; J Gluth; K Schell; J Criscola; C Friason; S Jones; S Nazarov; J Barzilay; N Rassouli; R Puttnam; B Ojoawo; R Nelson; M Curtis; B Hollis; C Sanders-Jones; K Stokes; Z El-Haqq; A Kolli; T Tran; D Wexler; ME Larkin; J Meigs; B Chambers; A Dushkin; G Rocchio; M Yepes; B Steiner; H Dulin; M Cayford; K Chu; A DeManbey; M Hillard; K Martin; N Thangthaeng; L Gurry; R Kochis; E Raymond; V Ripley; C Stevens; J Park; V Aroda; A Ghazi; M Magee; A Ressing; A Loveland; M Hamm; M Hurtado; A Kuhn; J Leger; L Manandhar; F Mwicigi; 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S Kunkel; F Ali Jamaleddin Ahmad; D Hernandez McGinnis; B Pucchetti; E Scripsick; A Zamorano; RA DeFronzo; E Cersosimo; M Abdul-Ghani; C Triplitt; D Juarez; M Mullen; RI Garza; H Verastiqui; K Wright; C Puckett; P Raskin; C Rhee; S Abraham; LF Jordan; S Sao; L Morton; O Smith; L Osornio Walker; L Schnurr-Breen; R Ayala; RB Kreymer; D Sturgess; KM Utzschneider; SE Kahn; L Alarcon-Casas Wright; EJ Boyko; EC Tsai; DL Trence; S Trikudanathan; BN Fattaleh; BK Montgomery; KM Atkinson; A Kozedub; T Concepcion; C Moak; N Prikhodko; S Rhothisen; TA Elasy; S Martin; L Shackelford; R Goidel; N Hinkle; C Lovell; J Myers; J Lipps Hogan; JB McGill; M Salam; T Schweiger; S Kissel; C Recklein; MJ Clifton; W Tamborlane; A Camp; B Gulanski; SE Inzucchi; K Pham; M Alguard; P Gatcomb; K Lessard; M Perez; L Iannone; E Magenheimer; A Montosa; J Fradkin; HB Burch; AA Bremer; DM Nathan; JM Lachin; H Krause-Steinrauf; N Younes; I Bebu; N Butera; CJ Buys; A Fagan; Y Gao; A Ghosh; MR Gramzinski; SD Hall; E Kazemi; E Legowski; H Liu; C Suratt; M Tripputi; A Arey; M Backman; J Bethepu; C Lund; P Mangat Dhaliwal; P McGee; E Mesimer; L Ngo; M Steffes; J Seegmiller; A Saenger; V Arends; D Gabrielson; T Conner; S Warren; J Day; J Huminik; A Scrymgeour; Y Pokharel; ZM Zhang; C Campbell; J Hu; L Keasler; S Hensley; Y Li; R Mihalcea; DJ Min; V Perez-Rosas; L Prosser; K Resnicow; W Ye; H Shao; P Zhang; D Sanchez; S Assuras; E Groessl; F Sakha; H Chong; N Hillery; BM Everett; I Abdouch; G Bahtiyar; P Brantley; FE Broyles; G Canaris; P Copeland; JJ Craine; WL Fein; A Gliwa; L Hope; MS Lee; R Meiners; V Meiners; H O'Neal; JE Park; A Sacerdote; E Sledge; L Soni; J Steppel-Reznik; A Turchin
- Accession Number: 0 (Insulin)
6KY687524K (glimepiride)
2ZM8CX04RZ (Insulin Glargine)
0 (Hypoglycemic Agents)
839I73S42A (Liraglutide)
0 (Glycated Hemoglobin)
0 (Blood Glucose)
9100L32L2N (Metformin)
TS63EW8X6F (Sitagliptin Phosphate)
0 (Insulin, Regular, Human)
0 (Sulfonylurea Compounds) - Publication Date: Date Created: 20230927 Date Completed: 20240327 Latest Revision: 20240404
- Publication Date: 20240404
- Accession Number: PMC10973913
- Accession Number: 10.2337/dc23-0516
- Accession Number: 37756542
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