Presentation and effectiveness of early treatment of type 2 diabetes in youth: lessons from the TODAY study

Megan M Kelsey, Mitchell E Geffner, Cynthia Guandalini, Laura Pyle, William V Tamborlane, Philip S Zeitler, Neil H White, Treatment Options for Type 2 Diabetes in Adolescents and Youth Study Group, S McKay, B Anderson, C Bush, S Gunn, M Haymond, H Holden, K Hwu, S M Jones, S McGirk, B Schreiner, S Thamotharan, M Zarate, L Cuttler, E Abrams, T Casey, W Dahms, A Davis, A Haider, S Huestis, 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, F Kaufman, E Law, V Mansilla, D Miller, C Muñoz, R Ortiz, J Sanchez, A Ward, K Wexler, Y K Xu, P Yasuda, L Levitt Katz, R Berkowitz, K Gralewski, B Johnson, J Kaplan, C Keating, C Lassiter, T Lipman, G McGinley, H McKnight, B Schwartzman, S Willi, S Arslanian, 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, R Rapaport, K Robbins, D Seidman, L Siegel-Czarkowski, P Speiser Joslin, L Laffel, A Goebel-Fabbri, M Hall, L Higgins, M Malloy, K Milaszewski, L Orkin, A Rodriguez-Ventura, D Nathan, L Bissett, K Blumenthal, L Delahanty, V Goldman, A Goseco, M Larkin, L Levitsky, R McEachern, K Milaszewski, D Norman, B Nwosu, S Park-Bennett, D Richards, N Sherry, B Steiner, S Tollefsen, 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, P Zeitler, N Abramson, A Bradhurst, N Celona-Jacobs, J Higgins, A Hull, M Kelsey, G Klingensmith, K Nadeau, T Witten, K Copeland, E Boss, R Brown, J Chadwick, L Chalmers, S Chernausek, C Macha, R Newgent, A Nordyke, D Olson, T Poulsen, L Pratt, J Preske, J Schanuel, J Smith, S Sternlof, R Swisher, 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, J Jones, T Jones, M Sadler, M Tanner, A Timpson, R Welch, S Caprio, M Grey, C Guandalini, S Lavietes, M Mignosa, P Rose, A Syme, W Tamborlane, K Hirst, S Edelstein, P Feit, N Grover, C Long, L Pyle, B Linder, S Marcovina, J Chmielewski, M Ramirez, G Strylewicz, J Shepherd, B Fan, L Marquez, M Sherman, J Wang, M Nichols, E Mayer-Davis, Y Liu, D Wilfley, D Aldrich-Rasche, K Franklin, D Laughlin, G Leibach, C Massmann, M Mills, D O'Brien, J Patterson, T Tibbs, D Van Buren, A Vannucci, P Zhang, J Silverstein, Megan M Kelsey, Mitchell E Geffner, Cynthia Guandalini, Laura Pyle, William V Tamborlane, Philip S Zeitler, Neil H White, Treatment Options for Type 2 Diabetes in Adolescents and Youth Study Group, S McKay, B Anderson, C Bush, S Gunn, M Haymond, H Holden, K Hwu, S M Jones, S McGirk, B Schreiner, S Thamotharan, M Zarate, L Cuttler, E Abrams, T Casey, W Dahms, A Davis, A Haider, S Huestis, 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, F Kaufman, E Law, V Mansilla, D Miller, C Muñoz, R Ortiz, J Sanchez, A Ward, K Wexler, Y K Xu, P Yasuda, L Levitt Katz, R Berkowitz, K Gralewski, B Johnson, J Kaplan, C Keating, C Lassiter, T Lipman, G McGinley, H McKnight, B Schwartzman, S Willi, S Arslanian, 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, R Rapaport, K Robbins, D Seidman, L Siegel-Czarkowski, P Speiser Joslin, L Laffel, A Goebel-Fabbri, M Hall, L Higgins, M Malloy, K Milaszewski, L Orkin, A Rodriguez-Ventura, D Nathan, L Bissett, K Blumenthal, L Delahanty, V Goldman, A Goseco, M Larkin, L Levitsky, R McEachern, K Milaszewski, D Norman, B Nwosu, S Park-Bennett, D Richards, N Sherry, B Steiner, S Tollefsen, 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, P Zeitler, N Abramson, A Bradhurst, N Celona-Jacobs, J Higgins, A Hull, M Kelsey, G Klingensmith, K Nadeau, T Witten, K Copeland, E Boss, R Brown, J Chadwick, L Chalmers, S Chernausek, C Macha, R Newgent, A Nordyke, D Olson, T Poulsen, L Pratt, J Preske, J Schanuel, J Smith, S Sternlof, R Swisher, 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, J Jones, T Jones, M Sadler, M Tanner, A Timpson, R Welch, S Caprio, M Grey, C Guandalini, S Lavietes, M Mignosa, P Rose, A Syme, W Tamborlane, K Hirst, S Edelstein, P Feit, N Grover, C Long, L Pyle, B Linder, S Marcovina, J Chmielewski, M Ramirez, G Strylewicz, J Shepherd, B Fan, L Marquez, M Sherman, J Wang, M Nichols, E Mayer-Davis, Y Liu, D Wilfley, D Aldrich-Rasche, K Franklin, D Laughlin, G Leibach, C Massmann, M Mills, D O'Brien, J Patterson, T Tibbs, D Van Buren, A Vannucci, P Zhang, J Silverstein

Abstract

Objective: The objectives were to (i) describe the characteristics of a large ethnically/racially and geographically diverse population of adolescents with recent-onset type 2 diabetes (T2D), and (ii) assess the effects of short-term diabetes education and treatment with metformin on clinical and biochemical parameters in this cohort.

Research design and methods: Descriptive characteristics were determined for subjects screened for Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) who met criteria for diagnosis of T2D (n = 1092). Changes in clinical and biochemical parameters were determined for those who completed at least 8 wk of the run-in phase of the trial, which included standardized diabetes education and treatment with metformin. Further analysis determined whether these changes differed according to the treatment at screening.

Main outcome measures: Demographic, biochemical measurements, and anthropometrics at screening and changes over 8 wk of run-in were the outcome measures.

Results: Subjects screened for TODAY had a median age of 14 yr and median hemoglobin A1c (HbA1c) of 6.9% (52 mM/M), 2/3 were female, and ethnic/racial minorities were overrepresented. Dyslipidemia and hypertension were common comorbidities. During run-in, HbA1c, body mass index, low-density lipoprotein cholesterol, triglycerides, and blood pressure significantly improved. Nearly all participants on insulin therapy at screening were able to attain target HbA1c following insulin discontinuation.

Conclusions: Treatment with metformin and diabetes education provided short-term improvements in glycemic control and cardiometabolic risk factors in a large adolescent T2D cohort. Nearly all insulin-treated youth could be successfully weaned off insulin with continued improvement in glycemic control.

Keywords: diabetes education; insulin therapy; metformin.

© 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Baseline weight status, HbA1c, and c-peptide by diabetes treatment at screening. Median baseline BMI z-score, HbA1c and c-peptide for all screened subjects with type 2 diabetes and by treatment at screening. Bottoms and tops of the boxes represent the 25th and 75th percentiles, respectively.
Figure 2
Figure 2
Median change in BMI z-score, HbA1c, and c-peptide from screening to end of run-in by diabetes treatment at screening. 2a) Median change in BMI z-score, HbA1c, and c-peptide for all subjects who completed at least 8 weeks of run-in. Changes in these parameters based on treatment at screening are also shown. P-values represent overall significance. *P

Figure 3

Change in proportion of subjects…

Figure 3

Change in proportion of subjects with cardiometabolic risk factors from screening to end…

Figure 3
Change in proportion of subjects with cardiometabolic risk factors from screening to end of run-in. Proportion of those who completed at least 8 weeks of run-in with poor glycemic control or other metabolic abnormalities. *P
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Figure 3
Figure 3
Change in proportion of subjects with cardiometabolic risk factors from screening to end of run-in. Proportion of those who completed at least 8 weeks of run-in with poor glycemic control or other metabolic abnormalities. *P

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