A clinical trial to maintain glycemic control in youth with type 2 diabetes

S. McKay; B. Anderson; C. Bush; S. Gunn; M. Haymond; H. Holden; SM Jones; N. Kamath; S. McGirk; B. Schreiner; S. Thamotharan; M. Zarate; E. Abrams; T. Casey; W. Dahms; A. Davis; A. Haider; C. Ievers-Landis; B. Kaminski; M. Koontz; S. MacLeish; P. McGuigan; S. Narasimhan; D. Rogers; M. Geffner; V. Barraza; N. Chang; B. Conrad; D. Dreimane; S. Estrada; L. Fisher; E. Fleury-Milfort; S. Hernandez; B. Hollen; E. Law; V. Mansilla; D. Miller; C. Muñoz; R. Ortiz; A. Ward; K. Wexler; YK Xu; P. Yasuda; L. Levitt Katz; R. Berkowitz; S. Boyd; B. Johnson; J. Kaplan; C. Keating; C. Lassiter; T. Lipman; G. McGinley; H. McKnight; B. Schwartzman; S. Willi; F. Bacha; S. Foster; B. Galvin; T. Hannon; A. Kriska; I. Libman; M. Marcus; K. Porter; T. Songer; E. Venditti; R. Goland; R. Cain; I. Fennoy; D. Gallagher; P. Kringas; N. Leibel; R. Motaghedi; D. Ng; M. Ovalles; M. Pellizzari; K. Robbins; D. Seidman; L. Siegel-Czarkowski; P. Speiser; L. Laffel; A. Goebel-Fabbri; M. Hall; L. Higgins; J. Keady; M. Malloy; K. Milaszewski; L. Orkin; A. Angelescu; L. Bissett; C. Ciccarelli; L. Delahanty; V. Goldman; O. Hardy; M. Larkin; L. Levitsky; R. McEachern; D. Norman; D. Nwosu; S. Park-Bennett; D. Richards; N. Sherry; B. Steiner; S. Carnes; D. Dempsher; D. Flomo; V. Kociela; T. Whelan; B. Wolff; R. Weinstock; D. Bowerman; S. Bristol; J. Bulger; J. Hartsig; R. Izquierdo; J. Kearns; R. Saletsky; P. Trief; N. Abramson; A. Bradhurst; N. Celona-Jacobs; M. Downey; J. Higgins; M. Kelsey; G. Klingensmith; K. Nadeau; T. Witten; E. Boss; R. Brown; J. Chadwick; L. Chalmers; S. Chernausek; A. Hebensperger; C. Macha; R. Newgent; A. Nordyke; D. Olson; T. Poulsen; L. Pratt; J. Preske; J. Schanuel; S. Sternlof; J. Lynch; N. Amodei; R. Barajas; C. Cody; D. Hale; J. Hernandez; C. Ibarra; E. Morales; S. Rivera; G. Rupert; A. Wauters; N. White; A. Arbeláez; D. Flomo; J. Jones; T. Jones; M. Sadler; M. Tanner; A. Timpson; R. Welch; S. Caprio; M. Grey; C. Guandalini; S. Lavietes; P. Rose; A. Syme; W. Tamborlane; S. Edelstein; P. Feit; N. Grover; C. Long; SM Marcovina; J. Harting; J. Shepherd; B. Fan; L. Marquez; M. Sherman; J. Wang; M. Nichols; E. Mayer-Davis; Y. Liu; J. Lima; S. Gidding; J. Puccella; E. Ricketts; R. Danis; A. Domalpally; A. Goulding; S. Neill; P. Vargo; D. Aldrich-Rasche; K. Franklin; C. Massmann; D. O'Brien; J. Patterson; T. Tibbs; D. Van Buren; M. Palmert; R. Ratner; D. Dremaine; J. Silverstein; Phil Zeitler; Kathryn Hirst; Laura Pyle; Barbara Linder; Kenneth Copeland; Silva Arslanian; Leona Cuttler; David M. Nathan; Sherida Tollefsen; Denise Wilfley; Francine Kaufman

doi:10.1056/NEJMoa1109333

A clinical trial to maintain glycemic control in youth with type 2 diabetes

S. McKay, B. Anderson, C. Bush, S. Gunn, M. Haymond, H. Holden, SM Jones, N. Kamath, S. McGirk, B. Schreiner, S. Thamotharan, M. Zarate, E. Abrams, T. Casey, W. Dahms, A. Davis, A. Haider, C. Ievers-Landis, B. Kaminski, M. KoontzS. MacLeish, P. McGuigan, S. Narasimhan, D. Rogers, M. Geffner, V. Barraza, N. Chang, B. Conrad, D. Dreimane, S. Estrada, L. Fisher, E. Fleury-Milfort, S. Hernandez, B. Hollen, E. Law, V. Mansilla, D. Miller, C. Muñoz, R. Ortiz, A. Ward, K. Wexler, YK Xu, P. Yasuda, L. Levitt Katz, R. Berkowitz, S. Boyd, B. Johnson, J. Kaplan, C. Keating, C. Lassiter, T. Lipman, G. McGinley, H. McKnight, B. Schwartzman, S. Willi, F. Bacha, S. Foster, B. Galvin, T. Hannon, A. Kriska, I. Libman, M. Marcus, K. Porter, T. Songer, E. Venditti, R. Goland, R. Cain, I. Fennoy, D. Gallagher, P. Kringas, N. Leibel, R. Motaghedi, D. Ng, M. Ovalles, M. Pellizzari, K. Robbins, D. Seidman, L. Siegel-Czarkowski, P. Speiser, L. Laffel, A. Goebel-Fabbri, M. Hall, L. Higgins, J. Keady, M. Malloy, K. Milaszewski, L. Orkin, A. Angelescu, L. Bissett, C. Ciccarelli, L. Delahanty, V. Goldman, O. Hardy, M. Larkin, L. Levitsky, R. McEachern, D. Norman, D. Nwosu, S. Park-Bennett, D. Richards, N. Sherry, B. Steiner, S. Carnes, D. Dempsher, D. Flomo, V. Kociela, T. Whelan, B. Wolff, R. Weinstock, D. Bowerman, S. Bristol, J. Bulger, J. Hartsig, R. Izquierdo, J. Kearns, R. Saletsky, P. Trief, N. Abramson, A. Bradhurst, N. Celona-Jacobs, M. Downey, J. Higgins, M. Kelsey, G. Klingensmith, K. Nadeau, T. Witten, E. Boss, R. Brown, J. Chadwick, L. Chalmers, S. Chernausek, A. Hebensperger, C. Macha, R. Newgent, A. Nordyke, D. Olson, T. Poulsen, L. Pratt, J. Preske, J. Schanuel, S. Sternlof, J. Lynch, N. Amodei, R. Barajas, C. Cody, D. Hale, J. Hernandez, C. Ibarra, E. Morales, S. Rivera, G. Rupert, A. Wauters, N. White, A. Arbeláez, D. Flomo, J. Jones, T. Jones, M. Sadler, M. Tanner, A. Timpson, R. Welch, S. Caprio, M. Grey, C. Guandalini, S. Lavietes, P. Rose, A. Syme, W. Tamborlane, S. Edelstein, P. Feit, N. Grover, C. Long, SM Marcovina, J. Harting, J. Shepherd, B. Fan, L. Marquez, M. Sherman, J. Wang, M. Nichols, E. Mayer-Davis, Y. Liu, J. Lima, S. Gidding, J. Puccella, E. Ricketts, R. Danis, A. Domalpally, A. Goulding, S. Neill, P. Vargo, D. Aldrich-Rasche, K. Franklin, C. Massmann, D. O'Brien, J. Patterson, T. Tibbs, D. Van Buren, M. Palmert, R. Ratner, D. Dremaine, J. Silverstein, Phil Zeitler, Kathryn Hirst, Laura Pyle, Barbara Linder, Kenneth Copeland, Silva Arslanian, Leona Cuttler, David M. Nathan, Sherida Tollefsen, Denise Wilfley, Francine Kaufman

Research output: Contribution to journal › Article › peer-review

749 Scopus citations

Abstract

BACKGROUND:Despite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes. METHODS:Eligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or sustained metabolic decompensation requiring insulin. RESULTS:Of the 699 randomly assigned participants (mean duration of diagnosed type 2 diabetes, 7.8 months), 319 (45.6%) reached the primary outcome over an average follow-up of 3.86 years. Rates of failure were 51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively. Metformin plus rosiglitazone was superior to metformin alone (P = 0.006); metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone. Prespecified analyses according to sex and race or ethnic group showed differences in sustained effectiveness, with metformin alone least effective in non- Hispanic black participants and metformin plus rosiglitazone most effective in girls. Serious adverse events were reported in 19.2% of participants. CONCLUSIONS: Monotherapy with metformin was associated with durable glycemic control in approximately half of children and adolescents with type 2 diabetes. The addition of rosiglitazone, but not an intensive lifestyle intervention, was superior to metformin alone. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; TODAY ClinicalTrials.gov number, NCT00081328.)

Original language	English
Pages (from-to)	2247-2256
Number of pages	10
Journal	New England Journal of Medicine
Volume	366
Issue number	24
DOIs	https://doi.org/10.1056/NEJMoa1109333
State	Published - Jun 14 2012

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10.1056/NEJMoa1109333

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McKay, S., Anderson, B., Bush, C., Gunn, S., Haymond, M., Holden, H., Jones, SM., Kamath, N., McGirk, S., Schreiner, B., Thamotharan, S., Zarate, M., Abrams, E., Casey, T., Dahms, W., Davis, A., Haider, A., Ievers-Landis, C., Kaminski, B., ... Kaufman, F. (2012). A clinical trial to maintain glycemic control in youth with type 2 diabetes. New England Journal of Medicine, 366(24), 2247-2256. https://doi.org/10.1056/NEJMoa1109333

@article{02a4f841e4064ad288b588e8bda29ff6,

title = "A clinical trial to maintain glycemic control in youth with type 2 diabetes",

abstract = "BACKGROUND:Despite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes. METHODS:Eligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or sustained metabolic decompensation requiring insulin. RESULTS:Of the 699 randomly assigned participants (mean duration of diagnosed type 2 diabetes, 7.8 months), 319 (45.6%) reached the primary outcome over an average follow-up of 3.86 years. Rates of failure were 51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively. Metformin plus rosiglitazone was superior to metformin alone (P = 0.006); metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone. Prespecified analyses according to sex and race or ethnic group showed differences in sustained effectiveness, with metformin alone least effective in non- Hispanic black participants and metformin plus rosiglitazone most effective in girls. Serious adverse events were reported in 19.2% of participants. CONCLUSIONS: Monotherapy with metformin was associated with durable glycemic control in approximately half of children and adolescents with type 2 diabetes. The addition of rosiglitazone, but not an intensive lifestyle intervention, was superior to metformin alone. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; TODAY ClinicalTrials.gov number, NCT00081328.)",

author = "S. McKay and B. Anderson and C. Bush and S. Gunn and M. Haymond and H. Holden and SM Jones and N. Kamath and S. McGirk and B. Schreiner and S. Thamotharan and M. Zarate and E. Abrams and T. Casey and W. Dahms and A. Davis and A. Haider and C. Ievers-Landis and B. Kaminski and M. Koontz and S. MacLeish and P. McGuigan and S. Narasimhan and D. Rogers and M. Geffner and V. Barraza and N. Chang and B. Conrad and D. Dreimane and S. Estrada and L. Fisher and E. Fleury-Milfort and S. Hernandez and B. Hollen and E. Law and V. Mansilla and D. Miller and C. Mu{\~n}oz and R. Ortiz and A. Ward and K. Wexler and YK Xu and P. Yasuda and {Levitt Katz}, L. and R. Berkowitz and S. Boyd and B. Johnson and J. Kaplan and C. Keating and C. Lassiter and T. Lipman and G. McGinley and H. McKnight and B. Schwartzman and S. Willi and F. Bacha and S. Foster and B. Galvin and T. Hannon and A. Kriska and I. Libman and M. Marcus and K. Porter and T. Songer and E. Venditti and R. Goland and R. Cain and I. Fennoy and D. Gallagher and P. Kringas and N. Leibel and R. Motaghedi and D. Ng and M. Ovalles and M. Pellizzari and K. Robbins and D. Seidman and L. Siegel-Czarkowski and P. Speiser and L. Laffel and A. Goebel-Fabbri and M. Hall and L. Higgins and J. Keady and M. Malloy and K. Milaszewski and L. Orkin and A. Angelescu and L. Bissett and C. Ciccarelli and L. Delahanty and V. Goldman and O. Hardy and M. Larkin and L. Levitsky and R. McEachern and D. Norman and D. Nwosu and S. Park-Bennett and D. Richards and N. Sherry and B. Steiner and S. Carnes and D. Dempsher and D. Flomo and V. Kociela and T. Whelan and B. Wolff and R. Weinstock and D. Bowerman and S. Bristol and J. Bulger and J. Hartsig and R. Izquierdo and J. Kearns and R. Saletsky and P. Trief and N. Abramson and A. Bradhurst and N. Celona-Jacobs and M. Downey and J. Higgins and M. Kelsey and G. Klingensmith and K. Nadeau and T. Witten and E. Boss and R. Brown and J. Chadwick and L. Chalmers and S. Chernausek and A. Hebensperger and C. Macha and R. Newgent and A. Nordyke and D. Olson and T. Poulsen and L. Pratt and J. Preske and J. Schanuel and S. Sternlof and J. Lynch and N. Amodei and R. Barajas and C. Cody and D. Hale and J. Hernandez and C. Ibarra and E. Morales and S. Rivera and G. Rupert and A. Wauters and N. White and A. Arbel{\'a}ez and D. Flomo and J. Jones and T. Jones and M. Sadler and M. Tanner and A. Timpson and R. Welch and S. Caprio and M. Grey and C. Guandalini and S. Lavietes and P. Rose and A. Syme and W. Tamborlane and S. Edelstein and P. Feit and N. Grover and C. Long and SM Marcovina and J. Harting and J. Shepherd and B. Fan and L. Marquez and M. Sherman and J. Wang and M. Nichols and E. Mayer-Davis and Y. Liu and J. Lima and S. Gidding and J. Puccella and E. Ricketts and R. Danis and A. Domalpally and A. Goulding and S. Neill and P. Vargo and D. Aldrich-Rasche and K. Franklin and C. Massmann and D. O'Brien and J. Patterson and T. Tibbs and {Van Buren}, D. and M. Palmert and R. Ratner and D. Dremaine and J. Silverstein and Phil Zeitler and Kathryn Hirst and Laura Pyle and Barbara Linder and Kenneth Copeland and Silva Arslanian and Leona Cuttler and Nathan, {David M.} and Sherida Tollefsen and Denise Wilfley and Francine Kaufman",

year = "2012",

month = jun,

day = "14",

doi = "10.1056/NEJMoa1109333",

language = "English",

volume = "366",

pages = "2247--2256",

journal = "New England Journal of Medicine",

issn = "0028-4793",

number = "24",

}

McKay, S, Anderson, B, Bush, C, Gunn, S, Haymond, M, Holden, H, Jones, SM, Kamath, N, McGirk, S, Schreiner, B, Thamotharan, S, Zarate, M, Abrams, E, Casey, T, Dahms, W, Davis, A, Haider, A, Ievers-Landis, C, Kaminski, B, Koontz, M, MacLeish, S, McGuigan, P, Narasimhan, S, Rogers, D, Geffner, M, Barraza, V, Chang, N, Conrad, B, Dreimane, D, Estrada, S, Fisher, L, Fleury-Milfort, E, Hernandez, S, Hollen, B, Law, E, Mansilla, V, Miller, D, Muñoz, C, Ortiz, R, Ward, A, Wexler, K, Xu, YK, Yasuda, P, Levitt Katz, L, Berkowitz, R, Boyd, S, Johnson, B, Kaplan, J, Keating, C, Lassiter, C, Lipman, T, McGinley, G, McKnight, H, Schwartzman, B, Willi, S, Bacha, F, Foster, S, Galvin, B, Hannon, T, Kriska, A, Libman, I, Marcus, M, Porter, K, Songer, T, Venditti, E, Goland, R, Cain, R, Fennoy, I, Gallagher, D, Kringas, P, Leibel, N, Motaghedi, R, Ng, D, Ovalles, M, Pellizzari, M, Robbins, K, Seidman, D, Siegel-Czarkowski, L, Speiser, P, Laffel, L, Goebel-Fabbri, A, Hall, M, Higgins, L, Keady, J, Malloy, M, Milaszewski, K, Orkin, L, Angelescu, A, Bissett, L, Ciccarelli, C, Delahanty, L, Goldman, V, Hardy, O, Larkin, M, Levitsky, L, McEachern, R, Norman, D, Nwosu, D, Park-Bennett, S, Richards, D, Sherry, N, Steiner, B, Carnes, S, Dempsher, D, Flomo, D, Kociela, V, Whelan, T, Wolff, B, Weinstock, R, Bowerman, D, Bristol, S, Bulger, J, Hartsig, J, Izquierdo, R, Kearns, J, Saletsky, R, Trief, P, Abramson, N, Bradhurst, A, Celona-Jacobs, N, Downey, M, Higgins, J, Kelsey, M, Klingensmith, G, Nadeau, K, Witten, T, Boss, E, Brown, R, Chadwick, J, Chalmers, L, Chernausek, S, Hebensperger, A, Macha, C, Newgent, R, Nordyke, A, Olson, D, Poulsen, T, Pratt, L, Preske, J, Schanuel, J, Sternlof, S, Lynch, J, Amodei, N, Barajas, R, Cody, C, Hale, D, Hernandez, J, Ibarra, C, Morales, E, Rivera, S, Rupert, G, Wauters, A, White, N, Arbeláez, A, Flomo, D, Jones, J, Jones, T, Sadler, M, Tanner, M, Timpson, A, Welch, R, Caprio, S, Grey, M, Guandalini, C, Lavietes, S, Rose, P, Syme, A, Tamborlane, W, Edelstein, S, Feit, P, Grover, N, Long, C, Marcovina, SM, Harting, J, Shepherd, J, Fan, B, Marquez, L, Sherman, M, Wang, J, Nichols, M, Mayer-Davis, E, Liu, Y, Lima, J, Gidding, S, Puccella, J, Ricketts, E, Danis, R, Domalpally, A, Goulding, A, Neill, S, Vargo, P, Aldrich-Rasche, D, Franklin, K, Massmann, C, O'Brien, D, Patterson, J, Tibbs, T, Van Buren, D, Palmert, M, Ratner, R, Dremaine, D, Silverstein, J, Zeitler, P, Hirst, K, Pyle, L, Linder, B, Copeland, K, Arslanian, S, Cuttler, L, Nathan, DM, Tollefsen, S, Wilfley, D & Kaufman, F 2012, 'A clinical trial to maintain glycemic control in youth with type 2 diabetes', New England Journal of Medicine, vol. 366, no. 24, pp. 2247-2256. https://doi.org/10.1056/NEJMoa1109333

TY - JOUR

T1 - A clinical trial to maintain glycemic control in youth with type 2 diabetes

AU - McKay, S.

AU - Anderson, B.

AU - Bush, C.

AU - Gunn, S.

AU - Haymond, M.

AU - Holden, H.

AU - Jones, SM

AU - Kamath, N.

AU - McGirk, S.

AU - Schreiner, B.

AU - Thamotharan, S.

AU - Zarate, M.

AU - Abrams, E.

AU - Casey, T.

AU - Dahms, W.

AU - Davis, A.

AU - Haider, A.

AU - Ievers-Landis, C.

AU - Kaminski, B.

AU - Koontz, M.

AU - MacLeish, S.

AU - McGuigan, P.

AU - Narasimhan, S.

AU - Rogers, D.

AU - Geffner, M.

AU - Barraza, V.

AU - Chang, N.

AU - Conrad, B.

AU - Dreimane, D.

AU - Estrada, S.

AU - Fisher, L.

AU - Fleury-Milfort, E.

AU - Hernandez, S.

AU - Hollen, B.

AU - Law, E.

AU - Mansilla, V.

AU - Miller, D.

AU - Muñoz, C.

AU - Ortiz, R.

AU - Ward, A.

AU - Wexler, K.

AU - Xu, YK

AU - Yasuda, P.

AU - Levitt Katz, L.

AU - Berkowitz, R.

AU - Boyd, S.

AU - Johnson, B.

AU - Kaplan, J.

AU - Keating, C.

AU - Lassiter, C.

AU - Lipman, T.

AU - McGinley, G.

AU - McKnight, H.

AU - Schwartzman, B.

AU - Willi, S.

AU - Bacha, F.

AU - Foster, S.

AU - Galvin, B.

AU - Hannon, T.

AU - Kriska, A.

AU - Libman, I.

AU - Marcus, M.

AU - Porter, K.

AU - Songer, T.

AU - Venditti, E.

AU - Goland, R.

AU - Cain, R.

AU - Fennoy, I.

AU - Gallagher, D.

AU - Kringas, P.

AU - Leibel, N.

AU - Motaghedi, R.

AU - Ng, D.

AU - Ovalles, M.

AU - Pellizzari, M.

AU - Robbins, K.

AU - Seidman, D.

AU - Siegel-Czarkowski, L.

AU - Speiser, P.

AU - Laffel, L.

AU - Goebel-Fabbri, A.

AU - Hall, M.

AU - Higgins, L.

AU - Keady, J.

AU - Malloy, M.

AU - Milaszewski, K.

AU - Orkin, L.

AU - Angelescu, A.

AU - Bissett, L.

AU - Ciccarelli, C.

AU - Delahanty, L.

AU - Goldman, V.

AU - Hardy, O.

AU - Larkin, M.

AU - Levitsky, L.

AU - McEachern, R.

AU - Norman, D.

AU - Nwosu, D.

AU - Park-Bennett, S.

AU - Richards, D.

AU - Sherry, N.

AU - Steiner, B.

AU - Carnes, S.

AU - Dempsher, D.

AU - Flomo, D.

AU - Kociela, V.

AU - Whelan, T.

AU - Wolff, B.

AU - Weinstock, R.

AU - Bowerman, D.

AU - Bristol, S.

AU - Bulger, J.

AU - Hartsig, J.

AU - Izquierdo, R.

AU - Kearns, J.

AU - Saletsky, R.

AU - Trief, P.

AU - Abramson, N.

AU - Bradhurst, A.

AU - Celona-Jacobs, N.

AU - Downey, M.

AU - Higgins, J.

AU - Kelsey, M.

AU - Klingensmith, G.

AU - Nadeau, K.

AU - Witten, T.

AU - Boss, E.

AU - Brown, R.

AU - Chadwick, J.

AU - Chalmers, L.

AU - Chernausek, S.

AU - Hebensperger, A.

AU - Macha, C.

AU - Newgent, R.

AU - Nordyke, A.

AU - Olson, D.

AU - Poulsen, T.

AU - Pratt, L.

AU - Preske, J.

AU - Schanuel, J.

AU - Sternlof, S.

AU - Lynch, J.

AU - Amodei, N.

AU - Barajas, R.

AU - Cody, C.

AU - Hale, D.

AU - Hernandez, J.

AU - Ibarra, C.

AU - Morales, E.

AU - Rivera, S.

AU - Rupert, G.

AU - Wauters, A.

AU - White, N.

AU - Arbeláez, A.

AU - Flomo, D.

AU - Jones, J.

AU - Jones, T.

AU - Sadler, M.

AU - Tanner, M.

AU - Timpson, A.

AU - Welch, R.

AU - Caprio, S.

AU - Grey, M.

AU - Guandalini, C.

AU - Lavietes, S.

AU - Rose, P.

AU - Syme, A.

AU - Tamborlane, W.

AU - Edelstein, S.

AU - Feit, P.

AU - Grover, N.

AU - Long, C.

AU - Marcovina, SM

AU - Harting, J.

AU - Shepherd, J.

AU - Fan, B.

AU - Marquez, L.

AU - Sherman, M.

AU - Wang, J.

AU - Nichols, M.

AU - Mayer-Davis, E.

AU - Liu, Y.

AU - Lima, J.

AU - Gidding, S.

AU - Puccella, J.

AU - Ricketts, E.

AU - Danis, R.

AU - Domalpally, A.

AU - Goulding, A.

AU - Neill, S.

AU - Vargo, P.

AU - Aldrich-Rasche, D.

AU - Franklin, K.

AU - Massmann, C.

AU - O'Brien, D.

AU - Patterson, J.

AU - Tibbs, T.

AU - Van Buren, D.

AU - Palmert, M.

AU - Ratner, R.

AU - Dremaine, D.

AU - Silverstein, J.

AU - Zeitler, Phil

AU - Hirst, Kathryn

AU - Pyle, Laura

AU - Linder, Barbara

AU - Copeland, Kenneth

AU - Arslanian, Silva

AU - Cuttler, Leona

AU - Nathan, David M.

AU - Tollefsen, Sherida

AU - Wilfley, Denise

AU - Kaufman, Francine

PY - 2012/6/14

Y1 - 2012/6/14

N2 - BACKGROUND:Despite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes. METHODS:Eligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or sustained metabolic decompensation requiring insulin. RESULTS:Of the 699 randomly assigned participants (mean duration of diagnosed type 2 diabetes, 7.8 months), 319 (45.6%) reached the primary outcome over an average follow-up of 3.86 years. Rates of failure were 51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively. Metformin plus rosiglitazone was superior to metformin alone (P = 0.006); metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone. Prespecified analyses according to sex and race or ethnic group showed differences in sustained effectiveness, with metformin alone least effective in non- Hispanic black participants and metformin plus rosiglitazone most effective in girls. Serious adverse events were reported in 19.2% of participants. CONCLUSIONS: Monotherapy with metformin was associated with durable glycemic control in approximately half of children and adolescents with type 2 diabetes. The addition of rosiglitazone, but not an intensive lifestyle intervention, was superior to metformin alone. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; TODAY ClinicalTrials.gov number, NCT00081328.)

AB - BACKGROUND:Despite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes. METHODS:Eligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or sustained metabolic decompensation requiring insulin. RESULTS:Of the 699 randomly assigned participants (mean duration of diagnosed type 2 diabetes, 7.8 months), 319 (45.6%) reached the primary outcome over an average follow-up of 3.86 years. Rates of failure were 51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively. Metformin plus rosiglitazone was superior to metformin alone (P = 0.006); metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone. Prespecified analyses according to sex and race or ethnic group showed differences in sustained effectiveness, with metformin alone least effective in non- Hispanic black participants and metformin plus rosiglitazone most effective in girls. Serious adverse events were reported in 19.2% of participants. CONCLUSIONS: Monotherapy with metformin was associated with durable glycemic control in approximately half of children and adolescents with type 2 diabetes. The addition of rosiglitazone, but not an intensive lifestyle intervention, was superior to metformin alone. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; TODAY ClinicalTrials.gov number, NCT00081328.)

UR - http://www.scopus.com/inward/record.url?scp=84862226987&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1109333

DO - 10.1056/NEJMoa1109333

M3 - Article

C2 - 22540912

AN - SCOPUS:84862226987

SN - 0028-4793

VL - 366

SP - 2247

EP - 2256

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 24

ER -

A clinical trial to maintain glycemic control in youth with type 2 diabetes

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