Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: A randomized, double-blind, non-inferiority trial

M. A. Nauck, G. Meininger, D. Sheng, L. Terranella, Peter P. Stein, P. Tesone, T. Davis, S. Colagiuri, R. Prager, G. Schernthaner, H. Toplak, T. Wascher, F. Coucke, M. De Meulemeester, J. Ducobu, J. Gross, M. T. Zanella, G. Godoy, E. Hernandez, V. ProfozicM. Kvapil, B. Tomas, P. Umlauf, J. Zemanova, K. Egstrup, A. Hansen, K. Hermansen, J. Eriksson, J. Lahtela, L. Niskanen, P. Salmela, B. Bauduceau, J. Bringer, G. Charpentier, M. Krempf, M. Marre, G. Weryha, J. Adler, H. Bouzo, K. M. Derwahl, M. Hanefeld, H. G. Kirchberg, G. Klausmann, C. Klein, R. Lehmann, M. Nauck, E. Oerter, E. D. Schulze, A. Weisbrod, K. Weyland, T. Zoller, K. Lam, J. Vadasz, G. Vandorfi, G. Baule, G. DeMattia, S. Gambardella, G. Ghirlanda, R. Lauro, S. Squatrito, L. Zabuliene, S. Chan, M. Mohamed, L. Sauque, W. A. de Backer, E. H R Wins, J. Benatar, R. Scott, J. Cooper, K. Furuseth, B. Kulseng, G. Molina, A. Rodriguez, E. Pacheco, K. Markiewicz, G. Pinis, J. Raposo, G. Teles, P. Eng, L. Burgess, R. Moore, J. Wing, A. Calle-Pascual, S. D. Garcia, F. V. Roca, J. L. Pino, J. M. Puig, E. Eizyk, A. Frid, P. A. Lagerback, U. Smith, M. Eddé, H. Saner, C. J. Chang, C. M. Hwu, S. T. Tu, R. Demirtunc, I. Satman, D. Haworth, P. Kopelman, R. Pieters, B. Silvert, R. Watt, Andrew Ahmann, S. Andrews, L. Barai, E. Barranco, R. Bettis, R. Blank, R. Brazg, S. Brazinsky, T. Bruya, F. Burch, E. Busick, R. Butcher, A. Caos, M. Chen, J. Clower, K. Cohen, G. Collins, J. Cook, M. Davidson, P. Denker, W. Drummond, J. Earl, A. Eisenberg, A. Forker, R. Garcia, H. Geisberg, J. Gilbert, R. Gilman, D. Gleason, R. Goldberg, F. Goldstein, S. Greco, P. Hollander, M. Jacobs, A. Jain, R. Kaplan, M. Kashyap, A. F. Kawley, H. Kerstein, Y. Khronusova, C. Laffer, A. Lewin, D. Linden, R. Lipetz, T. Littlejohn, J. Lochner, S. Mather, J. McGettigan, R. McNeill, N. Mezitis, J. Mitchell, L. Morales, A. Odugbesan, L. Padget, N. Patel, R. Pratley, J. Reusch, J. Robinson, J. Ruckle, M. Sandberg, M. J. Schear, D. Schumacher, R. Severance, J. Shapiro, M. Shomali, D. Silkiner, H. Simon, P. Smith, J. Stevens, G. Umpierrez, R. Wade, M. Weerasinghe, M. Weinberg, B. Wittmer, S. Yale

Research output: Contribution to journalArticle

559 Citations (Scopus)

Abstract

Aim: To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A1c (HbA1c) ≥ 6.5 and ≤10%] on metformin monotherapy. Methods: After a metformin dose titration/stabilization period (≥1500 mg/day), 1172 patients were randomized to the addition of sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (uptitrated to a potential maximum 20 mg/day) (N = 584) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA1c changes from baseline at Week 52 using a per-protocol approach. Results: From a mean baseline of 7.5%, HbA1c changes from baseline were -0.67% at Week 52 in both groups, confirming non-inferiority. The proportions achieving an HbA1c <7% were 63% (sitagliptin) and 59% (glipizide). Fasting plasma glucose changes from baseline were -0.56 mmol/l (-10.0 mg/dl) and -0.42 mmol/l (-7.5 mg/dl) for sitagliptin and glipizide, respectively. The proportion of patients experiencing hypoglycaemia episodes was significantly (p <0.001) higher with glipizide (32%) than with sitagliptin (5%), with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients. Sitagliptin led to weight loss (change from baseline = -1.5 kg) compared with weight gain (+1.1 kg) with glipizide [between-treatment difference (95% confidence interval) = -2.5 kg (-3.1, -2.0); p <0.001]. Conclusions: In this study, the addition of sitagliptin compared with glipizide provided similar HbA1c-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide.

Original languageEnglish (US)
Pages (from-to)194-205
Number of pages12
JournalDiabetes, Obesity and Metabolism
Volume9
Issue number2
DOIs
StatePublished - Mar 2007
Externally publishedYes

Fingerprint

Glipizide
Dipeptidyl-Peptidase IV Inhibitors
Metformin
Type 2 Diabetes Mellitus
Safety
Hemoglobins
Hypoglycemia
Weight Gain
Weight Loss
Sitagliptin Phosphate
Fasting

Keywords

  • Dipeptidyl peptidase-IV
  • DPP-IV
  • Incretins
  • MK-0431
  • Sulfonylureas

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone : A randomized, double-blind, non-inferiority trial. / Nauck, M. A.; Meininger, G.; Sheng, D.; Terranella, L.; Stein, Peter P.; Tesone, P.; Davis, T.; Colagiuri, S.; Prager, R.; Schernthaner, G.; Toplak, H.; Wascher, T.; Coucke, F.; De Meulemeester, M.; Ducobu, J.; Gross, J.; Zanella, M. T.; Godoy, G.; Hernandez, E.; Profozic, V.; Kvapil, M.; Tomas, B.; Umlauf, P.; Zemanova, J.; Egstrup, K.; Hansen, A.; Hermansen, K.; Eriksson, J.; Lahtela, J.; Niskanen, L.; Salmela, P.; Bauduceau, B.; Bringer, J.; Charpentier, G.; Krempf, M.; Marre, M.; Weryha, G.; Adler, J.; Bouzo, H.; Derwahl, K. M.; Hanefeld, M.; Kirchberg, H. G.; Klausmann, G.; Klein, C.; Lehmann, R.; Nauck, M.; Oerter, E.; Schulze, E. D.; Weisbrod, A.; Weyland, K.; Zoller, T.; Lam, K.; Vadasz, J.; Vandorfi, G.; Baule, G.; DeMattia, G.; Gambardella, S.; Ghirlanda, G.; Lauro, R.; Squatrito, S.; Zabuliene, L.; Chan, S.; Mohamed, M.; Sauque, L.; de Backer, W. A.; Wins, E. H R; Benatar, J.; Scott, R.; Cooper, J.; Furuseth, K.; Kulseng, B.; Molina, G.; Rodriguez, A.; Pacheco, E.; Markiewicz, K.; Pinis, G.; Raposo, J.; Teles, G.; Eng, P.; Burgess, L.; Moore, R.; Wing, J.; Calle-Pascual, A.; Garcia, S. D.; Roca, F. V.; Pino, J. L.; Puig, J. M.; Eizyk, E.; Frid, A.; Lagerback, P. A.; Smith, U.; Eddé, M.; Saner, H.; Chang, C. J.; Hwu, C. M.; Tu, S. T.; Demirtunc, R.; Satman, I.; Haworth, D.; Kopelman, P.; Pieters, R.; Silvert, B.; Watt, R.; Ahmann, Andrew; Andrews, S.; Barai, L.; Barranco, E.; Bettis, R.; Blank, R.; Brazg, R.; Brazinsky, S.; Bruya, T.; Burch, F.; Busick, E.; Butcher, R.; Caos, A.; Chen, M.; Clower, J.; Cohen, K.; Collins, G.; Cook, J.; Davidson, M.; Denker, P.; Drummond, W.; Earl, J.; Eisenberg, A.; Forker, A.; Garcia, R.; Geisberg, H.; Gilbert, J.; Gilman, R.; Gleason, D.; Goldberg, R.; Goldstein, F.; Greco, S.; Hollander, P.; Jacobs, M.; Jain, A.; Kaplan, R.; Kashyap, M.; Kawley, A. F.; Kerstein, H.; Khronusova, Y.; Laffer, C.; Lewin, A.; Linden, D.; Lipetz, R.; Littlejohn, T.; Lochner, J.; Mather, S.; McGettigan, J.; McNeill, R.; Mezitis, N.; Mitchell, J.; Morales, L.; Odugbesan, A.; Padget, L.; Patel, N.; Pratley, R.; Reusch, J.; Robinson, J.; Ruckle, J.; Sandberg, M.; Schear, M. J.; Schumacher, D.; Severance, R.; Shapiro, J.; Shomali, M.; Silkiner, D.; Simon, H.; Smith, P.; Stevens, J.; Umpierrez, G.; Wade, R.; Weerasinghe, M.; Weinberg, M.; Wittmer, B.; Yale, S.

In: Diabetes, Obesity and Metabolism, Vol. 9, No. 2, 03.2007, p. 194-205.

Research output: Contribution to journalArticle

Nauck, MA, Meininger, G, Sheng, D, Terranella, L, Stein, PP, Tesone, P, Davis, T, Colagiuri, S, Prager, R, Schernthaner, G, Toplak, H, Wascher, T, Coucke, F, De Meulemeester, M, Ducobu, J, Gross, J, Zanella, MT, Godoy, G, Hernandez, E, Profozic, V, Kvapil, M, Tomas, B, Umlauf, P, Zemanova, J, Egstrup, K, Hansen, A, Hermansen, K, Eriksson, J, Lahtela, J, Niskanen, L, Salmela, P, Bauduceau, B, Bringer, J, Charpentier, G, Krempf, M, Marre, M, Weryha, G, Adler, J, Bouzo, H, Derwahl, KM, Hanefeld, M, Kirchberg, HG, Klausmann, G, Klein, C, Lehmann, R, Nauck, M, Oerter, E, Schulze, ED, Weisbrod, A, Weyland, K, Zoller, T, Lam, K, Vadasz, J, Vandorfi, G, Baule, G, DeMattia, G, Gambardella, S, Ghirlanda, G, Lauro, R, Squatrito, S, Zabuliene, L, Chan, S, Mohamed, M, Sauque, L, de Backer, WA, Wins, EHR, Benatar, J, Scott, R, Cooper, J, Furuseth, K, Kulseng, B, Molina, G, Rodriguez, A, Pacheco, E, Markiewicz, K, Pinis, G, Raposo, J, Teles, G, Eng, P, Burgess, L, Moore, R, Wing, J, Calle-Pascual, A, Garcia, SD, Roca, FV, Pino, JL, Puig, JM, Eizyk, E, Frid, A, Lagerback, PA, Smith, U, Eddé, M, Saner, H, Chang, CJ, Hwu, CM, Tu, ST, Demirtunc, R, Satman, I, Haworth, D, Kopelman, P, Pieters, R, Silvert, B, Watt, R, Ahmann, A, Andrews, S, Barai, L, Barranco, E, Bettis, R, Blank, R, Brazg, R, Brazinsky, S, Bruya, T, Burch, F, Busick, E, Butcher, R, Caos, A, Chen, M, Clower, J, Cohen, K, Collins, G, Cook, J, Davidson, M, Denker, P, Drummond, W, Earl, J, Eisenberg, A, Forker, A, Garcia, R, Geisberg, H, Gilbert, J, Gilman, R, Gleason, D, Goldberg, R, Goldstein, F, Greco, S, Hollander, P, Jacobs, M, Jain, A, Kaplan, R, Kashyap, M, Kawley, AF, Kerstein, H, Khronusova, Y, Laffer, C, Lewin, A, Linden, D, Lipetz, R, Littlejohn, T, Lochner, J, Mather, S, McGettigan, J, McNeill, R, Mezitis, N, Mitchell, J, Morales, L, Odugbesan, A, Padget, L, Patel, N, Pratley, R, Reusch, J, Robinson, J, Ruckle, J, Sandberg, M, Schear, MJ, Schumacher, D, Severance, R, Shapiro, J, Shomali, M, Silkiner, D, Simon, H, Smith, P, Stevens, J, Umpierrez, G, Wade, R, Weerasinghe, M, Weinberg, M, Wittmer, B & Yale, S 2007, 'Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: A randomized, double-blind, non-inferiority trial', Diabetes, Obesity and Metabolism, vol. 9, no. 2, pp. 194-205. https://doi.org/10.1111/j.1463-1326.2006.00704.x
Nauck, M. A. ; Meininger, G. ; Sheng, D. ; Terranella, L. ; Stein, Peter P. ; Tesone, P. ; Davis, T. ; Colagiuri, S. ; Prager, R. ; Schernthaner, G. ; Toplak, H. ; Wascher, T. ; Coucke, F. ; De Meulemeester, M. ; Ducobu, J. ; Gross, J. ; Zanella, M. T. ; Godoy, G. ; Hernandez, E. ; Profozic, V. ; Kvapil, M. ; Tomas, B. ; Umlauf, P. ; Zemanova, J. ; Egstrup, K. ; Hansen, A. ; Hermansen, K. ; Eriksson, J. ; Lahtela, J. ; Niskanen, L. ; Salmela, P. ; Bauduceau, B. ; Bringer, J. ; Charpentier, G. ; Krempf, M. ; Marre, M. ; Weryha, G. ; Adler, J. ; Bouzo, H. ; Derwahl, K. M. ; Hanefeld, M. ; Kirchberg, H. G. ; Klausmann, G. ; Klein, C. ; Lehmann, R. ; Nauck, M. ; Oerter, E. ; Schulze, E. D. ; Weisbrod, A. ; Weyland, K. ; Zoller, T. ; Lam, K. ; Vadasz, J. ; Vandorfi, G. ; Baule, G. ; DeMattia, G. ; Gambardella, S. ; Ghirlanda, G. ; Lauro, R. ; Squatrito, S. ; Zabuliene, L. ; Chan, S. ; Mohamed, M. ; Sauque, L. ; de Backer, W. A. ; Wins, E. H R ; Benatar, J. ; Scott, R. ; Cooper, J. ; Furuseth, K. ; Kulseng, B. ; Molina, G. ; Rodriguez, A. ; Pacheco, E. ; Markiewicz, K. ; Pinis, G. ; Raposo, J. ; Teles, G. ; Eng, P. ; Burgess, L. ; Moore, R. ; Wing, J. ; Calle-Pascual, A. ; Garcia, S. D. ; Roca, F. V. ; Pino, J. L. ; Puig, J. M. ; Eizyk, E. ; Frid, A. ; Lagerback, P. A. ; Smith, U. ; Eddé, M. ; Saner, H. ; Chang, C. J. ; Hwu, C. M. ; Tu, S. T. ; Demirtunc, R. ; Satman, I. ; Haworth, D. ; Kopelman, P. ; Pieters, R. ; Silvert, B. ; Watt, R. ; Ahmann, Andrew ; Andrews, S. ; Barai, L. ; Barranco, E. ; Bettis, R. ; Blank, R. ; Brazg, R. ; Brazinsky, S. ; Bruya, T. ; Burch, F. ; Busick, E. ; Butcher, R. ; Caos, A. ; Chen, M. ; Clower, J. ; Cohen, K. ; Collins, G. ; Cook, J. ; Davidson, M. ; Denker, P. ; Drummond, W. ; Earl, J. ; Eisenberg, A. ; Forker, A. ; Garcia, R. ; Geisberg, H. ; Gilbert, J. ; Gilman, R. ; Gleason, D. ; Goldberg, R. ; Goldstein, F. ; Greco, S. ; Hollander, P. ; Jacobs, M. ; Jain, A. ; Kaplan, R. ; Kashyap, M. ; Kawley, A. F. ; Kerstein, H. ; Khronusova, Y. ; Laffer, C. ; Lewin, A. ; Linden, D. ; Lipetz, R. ; Littlejohn, T. ; Lochner, J. ; Mather, S. ; McGettigan, J. ; McNeill, R. ; Mezitis, N. ; Mitchell, J. ; Morales, L. ; Odugbesan, A. ; Padget, L. ; Patel, N. ; Pratley, R. ; Reusch, J. ; Robinson, J. ; Ruckle, J. ; Sandberg, M. ; Schear, M. J. ; Schumacher, D. ; Severance, R. ; Shapiro, J. ; Shomali, M. ; Silkiner, D. ; Simon, H. ; Smith, P. ; Stevens, J. ; Umpierrez, G. ; Wade, R. ; Weerasinghe, M. ; Weinberg, M. ; Wittmer, B. ; Yale, S. / Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone : A randomized, double-blind, non-inferiority trial. In: Diabetes, Obesity and Metabolism. 2007 ; Vol. 9, No. 2. pp. 194-205.
@article{a15667003f034ef5ba498c07f3cc61a7,
title = "Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: A randomized, double-blind, non-inferiority trial",
abstract = "Aim: To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A1c (HbA1c) ≥ 6.5 and ≤10{\%}] on metformin monotherapy. Methods: After a metformin dose titration/stabilization period (≥1500 mg/day), 1172 patients were randomized to the addition of sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (uptitrated to a potential maximum 20 mg/day) (N = 584) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA1c changes from baseline at Week 52 using a per-protocol approach. Results: From a mean baseline of 7.5{\%}, HbA1c changes from baseline were -0.67{\%} at Week 52 in both groups, confirming non-inferiority. The proportions achieving an HbA1c <7{\%} were 63{\%} (sitagliptin) and 59{\%} (glipizide). Fasting plasma glucose changes from baseline were -0.56 mmol/l (-10.0 mg/dl) and -0.42 mmol/l (-7.5 mg/dl) for sitagliptin and glipizide, respectively. The proportion of patients experiencing hypoglycaemia episodes was significantly (p <0.001) higher with glipizide (32{\%}) than with sitagliptin (5{\%}), with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients. Sitagliptin led to weight loss (change from baseline = -1.5 kg) compared with weight gain (+1.1 kg) with glipizide [between-treatment difference (95{\%} confidence interval) = -2.5 kg (-3.1, -2.0); p <0.001]. Conclusions: In this study, the addition of sitagliptin compared with glipizide provided similar HbA1c-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide.",
keywords = "Dipeptidyl peptidase-IV, DPP-IV, Incretins, MK-0431, Sulfonylureas",
author = "Nauck, {M. A.} and G. Meininger and D. Sheng and L. Terranella and Stein, {Peter P.} and P. Tesone and T. Davis and S. Colagiuri and R. Prager and G. Schernthaner and H. Toplak and T. Wascher and F. Coucke and {De Meulemeester}, M. and J. Ducobu and J. Gross and Zanella, {M. T.} and G. Godoy and E. Hernandez and V. Profozic and M. Kvapil and B. Tomas and P. Umlauf and J. Zemanova and K. Egstrup and A. Hansen and K. Hermansen and J. Eriksson and J. Lahtela and L. Niskanen and P. Salmela and B. Bauduceau and J. Bringer and G. Charpentier and M. Krempf and M. Marre and G. Weryha and J. Adler and H. Bouzo and Derwahl, {K. M.} and M. Hanefeld and Kirchberg, {H. G.} and G. Klausmann and C. Klein and R. Lehmann and M. Nauck and E. Oerter and Schulze, {E. D.} and A. Weisbrod and K. Weyland and T. Zoller and K. Lam and J. Vadasz and G. Vandorfi and G. Baule and G. DeMattia and S. Gambardella and G. Ghirlanda and R. Lauro and S. Squatrito and L. Zabuliene and S. Chan and M. Mohamed and L. Sauque and {de Backer}, {W. A.} and Wins, {E. H R} and J. Benatar and R. Scott and J. Cooper and K. Furuseth and B. Kulseng and G. Molina and A. Rodriguez and E. Pacheco and K. Markiewicz and G. Pinis and J. Raposo and G. Teles and P. Eng and L. Burgess and R. Moore and J. Wing and A. Calle-Pascual and Garcia, {S. D.} and Roca, {F. V.} and Pino, {J. L.} and Puig, {J. M.} and E. Eizyk and A. Frid and Lagerback, {P. A.} and U. Smith and M. Edd{\'e} and H. Saner and Chang, {C. J.} and Hwu, {C. M.} and Tu, {S. T.} and R. Demirtunc and I. Satman and D. Haworth and P. Kopelman and R. Pieters and B. Silvert and R. Watt and Andrew Ahmann and S. Andrews and L. Barai and E. Barranco and R. Bettis and R. Blank and R. Brazg and S. Brazinsky and T. Bruya and F. Burch and E. Busick and R. Butcher and A. Caos and M. Chen and J. Clower and K. Cohen and G. Collins and J. Cook and M. Davidson and P. Denker and W. Drummond and J. Earl and A. Eisenberg and A. Forker and R. Garcia and H. Geisberg and J. Gilbert and R. Gilman and D. Gleason and R. Goldberg and F. Goldstein and S. Greco and P. Hollander and M. Jacobs and A. Jain and R. Kaplan and M. Kashyap and Kawley, {A. F.} and H. Kerstein and Y. Khronusova and C. Laffer and A. Lewin and D. Linden and R. Lipetz and T. Littlejohn and J. Lochner and S. Mather and J. McGettigan and R. McNeill and N. Mezitis and J. Mitchell and L. Morales and A. Odugbesan and L. Padget and N. Patel and R. Pratley and J. Reusch and J. Robinson and J. Ruckle and M. Sandberg and Schear, {M. J.} and D. Schumacher and R. Severance and J. Shapiro and M. Shomali and D. Silkiner and H. Simon and P. Smith and J. Stevens and G. Umpierrez and R. Wade and M. Weerasinghe and M. Weinberg and B. Wittmer and S. Yale",
year = "2007",
month = "3",
doi = "10.1111/j.1463-1326.2006.00704.x",
language = "English (US)",
volume = "9",
pages = "194--205",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "2",

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TY - JOUR

T1 - Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone

T2 - A randomized, double-blind, non-inferiority trial

AU - Nauck, M. A.

AU - Meininger, G.

AU - Sheng, D.

AU - Terranella, L.

AU - Stein, Peter P.

AU - Tesone, P.

AU - Davis, T.

AU - Colagiuri, S.

AU - Prager, R.

AU - Schernthaner, G.

AU - Toplak, H.

AU - Wascher, T.

AU - Coucke, F.

AU - De Meulemeester, M.

AU - Ducobu, J.

AU - Gross, J.

AU - Zanella, M. T.

AU - Godoy, G.

AU - Hernandez, E.

AU - Profozic, V.

AU - Kvapil, M.

AU - Tomas, B.

AU - Umlauf, P.

AU - Zemanova, J.

AU - Egstrup, K.

AU - Hansen, A.

AU - Hermansen, K.

AU - Eriksson, J.

AU - Lahtela, J.

AU - Niskanen, L.

AU - Salmela, P.

AU - Bauduceau, B.

AU - Bringer, J.

AU - Charpentier, G.

AU - Krempf, M.

AU - Marre, M.

AU - Weryha, G.

AU - Adler, J.

AU - Bouzo, H.

AU - Derwahl, K. M.

AU - Hanefeld, M.

AU - Kirchberg, H. G.

AU - Klausmann, G.

AU - Klein, C.

AU - Lehmann, R.

AU - Nauck, M.

AU - Oerter, E.

AU - Schulze, E. D.

AU - Weisbrod, A.

AU - Weyland, K.

AU - Zoller, T.

AU - Lam, K.

AU - Vadasz, J.

AU - Vandorfi, G.

AU - Baule, G.

AU - DeMattia, G.

AU - Gambardella, S.

AU - Ghirlanda, G.

AU - Lauro, R.

AU - Squatrito, S.

AU - Zabuliene, L.

AU - Chan, S.

AU - Mohamed, M.

AU - Sauque, L.

AU - de Backer, W. A.

AU - Wins, E. H R

AU - Benatar, J.

AU - Scott, R.

AU - Cooper, J.

AU - Furuseth, K.

AU - Kulseng, B.

AU - Molina, G.

AU - Rodriguez, A.

AU - Pacheco, E.

AU - Markiewicz, K.

AU - Pinis, G.

AU - Raposo, J.

AU - Teles, G.

AU - Eng, P.

AU - Burgess, L.

AU - Moore, R.

AU - Wing, J.

AU - Calle-Pascual, A.

AU - Garcia, S. D.

AU - Roca, F. V.

AU - Pino, J. L.

AU - Puig, J. M.

AU - Eizyk, E.

AU - Frid, A.

AU - Lagerback, P. A.

AU - Smith, U.

AU - Eddé, M.

AU - Saner, H.

AU - Chang, C. J.

AU - Hwu, C. M.

AU - Tu, S. T.

AU - Demirtunc, R.

AU - Satman, I.

AU - Haworth, D.

AU - Kopelman, P.

AU - Pieters, R.

AU - Silvert, B.

AU - Watt, R.

AU - Ahmann, Andrew

AU - Andrews, S.

AU - Barai, L.

AU - Barranco, E.

AU - Bettis, R.

AU - Blank, R.

AU - Brazg, R.

AU - Brazinsky, S.

AU - Bruya, T.

AU - Burch, F.

AU - Busick, E.

AU - Butcher, R.

AU - Caos, A.

AU - Chen, M.

AU - Clower, J.

AU - Cohen, K.

AU - Collins, G.

AU - Cook, J.

AU - Davidson, M.

AU - Denker, P.

AU - Drummond, W.

AU - Earl, J.

AU - Eisenberg, A.

AU - Forker, A.

AU - Garcia, R.

AU - Geisberg, H.

AU - Gilbert, J.

AU - Gilman, R.

AU - Gleason, D.

AU - Goldberg, R.

AU - Goldstein, F.

AU - Greco, S.

AU - Hollander, P.

AU - Jacobs, M.

AU - Jain, A.

AU - Kaplan, R.

AU - Kashyap, M.

AU - Kawley, A. F.

AU - Kerstein, H.

AU - Khronusova, Y.

AU - Laffer, C.

AU - Lewin, A.

AU - Linden, D.

AU - Lipetz, R.

AU - Littlejohn, T.

AU - Lochner, J.

AU - Mather, S.

AU - McGettigan, J.

AU - McNeill, R.

AU - Mezitis, N.

AU - Mitchell, J.

AU - Morales, L.

AU - Odugbesan, A.

AU - Padget, L.

AU - Patel, N.

AU - Pratley, R.

AU - Reusch, J.

AU - Robinson, J.

AU - Ruckle, J.

AU - Sandberg, M.

AU - Schear, M. J.

AU - Schumacher, D.

AU - Severance, R.

AU - Shapiro, J.

AU - Shomali, M.

AU - Silkiner, D.

AU - Simon, H.

AU - Smith, P.

AU - Stevens, J.

AU - Umpierrez, G.

AU - Wade, R.

AU - Weerasinghe, M.

AU - Weinberg, M.

AU - Wittmer, B.

AU - Yale, S.

PY - 2007/3

Y1 - 2007/3

N2 - Aim: To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A1c (HbA1c) ≥ 6.5 and ≤10%] on metformin monotherapy. Methods: After a metformin dose titration/stabilization period (≥1500 mg/day), 1172 patients were randomized to the addition of sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (uptitrated to a potential maximum 20 mg/day) (N = 584) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA1c changes from baseline at Week 52 using a per-protocol approach. Results: From a mean baseline of 7.5%, HbA1c changes from baseline were -0.67% at Week 52 in both groups, confirming non-inferiority. The proportions achieving an HbA1c <7% were 63% (sitagliptin) and 59% (glipizide). Fasting plasma glucose changes from baseline were -0.56 mmol/l (-10.0 mg/dl) and -0.42 mmol/l (-7.5 mg/dl) for sitagliptin and glipizide, respectively. The proportion of patients experiencing hypoglycaemia episodes was significantly (p <0.001) higher with glipizide (32%) than with sitagliptin (5%), with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients. Sitagliptin led to weight loss (change from baseline = -1.5 kg) compared with weight gain (+1.1 kg) with glipizide [between-treatment difference (95% confidence interval) = -2.5 kg (-3.1, -2.0); p <0.001]. Conclusions: In this study, the addition of sitagliptin compared with glipizide provided similar HbA1c-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide.

AB - Aim: To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A1c (HbA1c) ≥ 6.5 and ≤10%] on metformin monotherapy. Methods: After a metformin dose titration/stabilization period (≥1500 mg/day), 1172 patients were randomized to the addition of sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (uptitrated to a potential maximum 20 mg/day) (N = 584) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA1c changes from baseline at Week 52 using a per-protocol approach. Results: From a mean baseline of 7.5%, HbA1c changes from baseline were -0.67% at Week 52 in both groups, confirming non-inferiority. The proportions achieving an HbA1c <7% were 63% (sitagliptin) and 59% (glipizide). Fasting plasma glucose changes from baseline were -0.56 mmol/l (-10.0 mg/dl) and -0.42 mmol/l (-7.5 mg/dl) for sitagliptin and glipizide, respectively. The proportion of patients experiencing hypoglycaemia episodes was significantly (p <0.001) higher with glipizide (32%) than with sitagliptin (5%), with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients. Sitagliptin led to weight loss (change from baseline = -1.5 kg) compared with weight gain (+1.1 kg) with glipizide [between-treatment difference (95% confidence interval) = -2.5 kg (-3.1, -2.0); p <0.001]. Conclusions: In this study, the addition of sitagliptin compared with glipizide provided similar HbA1c-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide.

KW - Dipeptidyl peptidase-IV

KW - DPP-IV

KW - Incretins

KW - MK-0431

KW - Sulfonylureas

UR - http://www.scopus.com/inward/record.url?scp=33846817233&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33846817233&partnerID=8YFLogxK

U2 - 10.1111/j.1463-1326.2006.00704.x

DO - 10.1111/j.1463-1326.2006.00704.x

M3 - Article

C2 - 17300595

AN - SCOPUS:33846817233

VL - 9

SP - 194

EP - 205

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 2

ER -