Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: A randomized controlled trial

M. Jadzinsky, A. Pfützner, E. Paz-Pacheco, Z. Xu, E. Allen, Roland Chen, P. Antunez, C. Baccaro, R. Bertone, J. Bragagnolo, C. S. Cordo, G. Dieuzeide, H. L. Fideleff, S. Hermida, J. Herrera, C. Issa, M. Jadzinsky, M. Kraft, L. Maffei, Z. ManG. Marcucci, A. Oviedo, J. M. Sanchez, G. Vines, F. Zambon, A. Chacra, F. Farias, J. Felicio, A. Forti, J. L. Gross, M. N. Hissa, N. Rassi, J. A. Sgarbi, A. Barakat, G. F. Böhm, M. Hanefeld, G. Illies, A. Kellner, G. Klausmann, C. Klein, A. Molle, M. Nauck, A. Pfützner, J. Sauter, J. Schaller, J. Wachter, G. Deák, M. Dudás, I. Foldesi, E. Harcsa, C. Salamon, R. P. Agarwal, S. R. Aravind, M. Dharmalingam, G. Jugal Bihari, S. Kale, S. Kalra, P. Kumar, S. Mahadevan, V. Mohan, P. Rao, S. Shah, N. Thomas, S. K. Wangnoo, E. Bosi, R. Cocchi, R. Cordera, G. Perriello, S. Squatrito, M. D R Arechavaleta Granell, G. Galvez Correa, P. A. Garcia Hernandez, N. Hernandez, C. Jerjes Sanchez, S. A. Jimenez Ramos, F. Lozano, C. Reyes, F. J. Robles Torres, L. Sauque Reyna, H. E. Tamez Perez, M. V. Velazquez, E. M. Villegas, K. Cimafranca, M. Denopol, C. Jimeno, M. Lim-Abrahan, A. Liwag, A. A. Panelo, E. Paz-Pacheco, G. H. Tan, T. Derezinski, W. Galczak, G. Jasieniak-Pinis, J. Mrozek, R. Petryka, E. Skokowska, T. Stasinska, K. Strojek, F. Abreu-Feshold, E. Barranco, J. Claudio, M. Sosa-Padilla, J. Vazquez-Tanus, S. Velazquez-Navarro, M. Antciferov, G. Arutunov, M. Balabolkin, O. Barbarash, I. Bokarev, I. Bondar, E. Bova, A. Dreval, E. Grineva, I. Gurieva, L. Ivanova, A. Ivleva, Y. Khalimov, Z. Kobalava, M. Kotelnikov, O. Lantseva, V. Marasaev, S. Nedogoda, N. Nosova, A. Ponomareva, E. Radygina, A. Ragozin, A. Rakov, A. Rebrov, G. Reshedko, O. Reshetko, T. Rodionova, G. Rodoman, L. Ruyatkina, O. Semenova, A. Sherenkov, S. Shustov, Y. Shvarts, E. Smirnova, O. Solovyev, L. Strongin, L. Suplotova, V. Trusov, S. Vorobyev, N. Vorokhobina, E. Voychik, V. Yakusevich, O. Zagrebelnaya, A. Zalevskaya, O. Zanozina, N. Zhavoronkova, L. Zhukova, A. Bazylevych, O. Girina, O. Levchenko, V. Netiazhenko, M. Perepelytsya, T. Pertseva, Y. Rudyk, Y. Slyvka, M. Vlasenko, A. Yagensky, R. Ashley, G. Atiee, S. D. Bleser, D. K. Bright, G. Bueso, D. K. Buth, H. Cabasares, M. E. Campolo, C. Chappel, S. E. Conard, J. Constantine, D. L. Dayon, D. Dionne, I. F. Fenton, R. Garcia, A. George, R. Gilman, L. Glaser, M. Gollapudi, J. Gray, W. J. Henry, A. Iranmanesh, R. Ison, R. K. Jacks, W. Jacks, M. Jain, G. Johnson, R. Kaplan, R. A. Khairi, J. LaBuda, J. LaSalle, M. K. Lawrence, R. S. Lipetz, S. Miller, R. Montoro, Y. Mora, A. Poindexter, J. F. Quigley, G. L. Raad, P. Rawtani, A. Schneider, S. Shah, J. Spence, D. Stanton, D. Sugimoto, F. L. Thomas, D. Weiss, P. Weissman, William Woodward

Research output: Contribution to journalArticle

245 Citations (Scopus)

Abstract

Aim: The study aim was to evaluate the efficacy and safety of initial combination therapy with saxagliptin + metformin vs. saxagliptin or metformin monotherapy in treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycaemic control. Methods: In this multicentre, randomized, double-blind, active-controlled phase 3 trial, 1306 treatment-naïve patients with T2D ≥18 to ≤77 years, glycosylated haemoglobin (HbA1c) ≥8 to ≤12%, fasting C-peptide concentration ≥1.0 ng/ml, body mass index ≤40 kg/m2 were randomized to receive saxagliptin 5 mg + metformin 500 mg, saxagliptin 10 mg + metformin 500 mg, saxagliptin 10 mg + placebo or metformin 500 mg + placebo for 24 weeks. From weeks 1-5, metformin was uptitrated in 500-mg/day increments to 2000 mg/day maximum in the saxagliptin 5 mg + metformin, saxagliptin 10 mg + metformin and metformin + placebo treatment groups. The main outcome measure was HbA1c change from baseline to week 24. Selected secondary outcomes included change from baseline to week 24 in fasting plasma glucose (FPG), proportion of patients achieving HbA1c

Original languageEnglish (US)
Pages (from-to)611-622
Number of pages12
JournalDiabetes, Obesity and Metabolism
Volume11
Issue number6
DOIs
StatePublished - 2009
Externally publishedYes

Fingerprint

Metformin
Type 2 Diabetes Mellitus
Randomized Controlled Trials
Therapeutics
Placebos
Fasting
saxagliptin
C-Peptide
Glycosylated Hemoglobin A
Body Mass Index
Outcome Assessment (Health Care)
Safety
Glucose

Keywords

  • DPP-4
  • Metformin
  • Saxagliptin
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy : A randomized controlled trial. / Jadzinsky, M.; Pfützner, A.; Paz-Pacheco, E.; Xu, Z.; Allen, E.; Chen, Roland; Antunez, P.; Baccaro, C.; Bertone, R.; Bragagnolo, J.; Cordo, C. S.; Dieuzeide, G.; Fideleff, H. L.; Hermida, S.; Herrera, J.; Issa, C.; Jadzinsky, M.; Kraft, M.; Maffei, L.; Man, Z.; Marcucci, G.; Oviedo, A.; Sanchez, J. M.; Vines, G.; Zambon, F.; Chacra, A.; Farias, F.; Felicio, J.; Forti, A.; Gross, J. L.; Hissa, M. N.; Rassi, N.; Sgarbi, J. A.; Barakat, A.; Böhm, G. F.; Hanefeld, M.; Illies, G.; Kellner, A.; Klausmann, G.; Klein, C.; Molle, A.; Nauck, M.; Pfützner, A.; Sauter, J.; Schaller, J.; Wachter, J.; Deák, G.; Dudás, M.; Foldesi, I.; Harcsa, E.; Salamon, C.; Agarwal, R. P.; Aravind, S. R.; Dharmalingam, M.; Jugal Bihari, G.; Kale, S.; Kalra, S.; Kumar, P.; Mahadevan, S.; Mohan, V.; Rao, P.; Shah, S.; Thomas, N.; Wangnoo, S. K.; Bosi, E.; Cocchi, R.; Cordera, R.; Perriello, G.; Squatrito, S.; Arechavaleta Granell, M. D R; Galvez Correa, G.; Garcia Hernandez, P. A.; Hernandez, N.; Jerjes Sanchez, C.; Jimenez Ramos, S. A.; Lozano, F.; Reyes, C.; Robles Torres, F. J.; Sauque Reyna, L.; Tamez Perez, H. E.; Velazquez, M. V.; Villegas, E. M.; Cimafranca, K.; Denopol, M.; Jimeno, C.; Lim-Abrahan, M.; Liwag, A.; Panelo, A. A.; Paz-Pacheco, E.; Tan, G. H.; Derezinski, T.; Galczak, W.; Jasieniak-Pinis, G.; Mrozek, J.; Petryka, R.; Skokowska, E.; Stasinska, T.; Strojek, K.; Abreu-Feshold, F.; Barranco, E.; Claudio, J.; Sosa-Padilla, M.; Vazquez-Tanus, J.; Velazquez-Navarro, S.; Antciferov, M.; Arutunov, G.; Balabolkin, M.; Barbarash, O.; Bokarev, I.; Bondar, I.; Bova, E.; Dreval, A.; Grineva, E.; Gurieva, I.; Ivanova, L.; Ivleva, A.; Khalimov, Y.; Kobalava, Z.; Kotelnikov, M.; Lantseva, O.; Marasaev, V.; Nedogoda, S.; Nosova, N.; Ponomareva, A.; Radygina, E.; Ragozin, A.; Rakov, A.; Rebrov, A.; Reshedko, G.; Reshetko, O.; Rodionova, T.; Rodoman, G.; Ruyatkina, L.; Semenova, O.; Sherenkov, A.; Shustov, S.; Shvarts, Y.; Smirnova, E.; Solovyev, O.; Strongin, L.; Suplotova, L.; Trusov, V.; Vorobyev, S.; Vorokhobina, N.; Voychik, E.; Yakusevich, V.; Zagrebelnaya, O.; Zalevskaya, A.; Zanozina, O.; Zhavoronkova, N.; Zhukova, L.; Bazylevych, A.; Girina, O.; Levchenko, O.; Netiazhenko, V.; Perepelytsya, M.; Pertseva, T.; Rudyk, Y.; Slyvka, Y.; Vlasenko, M.; Yagensky, A.; Ashley, R.; Atiee, G.; Bleser, S. D.; Bright, D. K.; Bueso, G.; Buth, D. K.; Cabasares, H.; Campolo, M. E.; Chappel, C.; Conard, S. E.; Constantine, J.; Dayon, D. L.; Dionne, D.; Fenton, I. F.; Garcia, R.; George, A.; Gilman, R.; Glaser, L.; Gollapudi, M.; Gray, J.; Henry, W. J.; Iranmanesh, A.; Ison, R.; Jacks, R. K.; Jacks, W.; Jain, M.; Johnson, G.; Kaplan, R.; Khairi, R. A.; LaBuda, J.; LaSalle, J.; Lawrence, M. K.; Lipetz, R. S.; Miller, S.; Montoro, R.; Mora, Y.; Poindexter, A.; Quigley, J. F.; Raad, G. L.; Rawtani, P.; Schneider, A.; Shah, S.; Spence, J.; Stanton, D.; Sugimoto, D.; Thomas, F. L.; Weiss, D.; Weissman, P.; Woodward, William.

In: Diabetes, Obesity and Metabolism, Vol. 11, No. 6, 2009, p. 611-622.

Research output: Contribution to journalArticle

Jadzinsky, M, Pfützner, A, Paz-Pacheco, E, Xu, Z, Allen, E, Chen, R, Antunez, P, Baccaro, C, Bertone, R, Bragagnolo, J, Cordo, CS, Dieuzeide, G, Fideleff, HL, Hermida, S, Herrera, J, Issa, C, Jadzinsky, M, Kraft, M, Maffei, L, Man, Z, Marcucci, G, Oviedo, A, Sanchez, JM, Vines, G, Zambon, F, Chacra, A, Farias, F, Felicio, J, Forti, A, Gross, JL, Hissa, MN, Rassi, N, Sgarbi, JA, Barakat, A, Böhm, GF, Hanefeld, M, Illies, G, Kellner, A, Klausmann, G, Klein, C, Molle, A, Nauck, M, Pfützner, A, Sauter, J, Schaller, J, Wachter, J, Deák, G, Dudás, M, Foldesi, I, Harcsa, E, Salamon, C, Agarwal, RP, Aravind, SR, Dharmalingam, M, Jugal Bihari, G, Kale, S, Kalra, S, Kumar, P, Mahadevan, S, Mohan, V, Rao, P, Shah, S, Thomas, N, Wangnoo, SK, Bosi, E, Cocchi, R, Cordera, R, Perriello, G, Squatrito, S, Arechavaleta Granell, MDR, Galvez Correa, G, Garcia Hernandez, PA, Hernandez, N, Jerjes Sanchez, C, Jimenez Ramos, SA, Lozano, F, Reyes, C, Robles Torres, FJ, Sauque Reyna, L, Tamez Perez, HE, Velazquez, MV, Villegas, EM, Cimafranca, K, Denopol, M, Jimeno, C, Lim-Abrahan, M, Liwag, A, Panelo, AA, Paz-Pacheco, E, Tan, GH, Derezinski, T, Galczak, W, Jasieniak-Pinis, G, Mrozek, J, Petryka, R, Skokowska, E, Stasinska, T, Strojek, K, Abreu-Feshold, F, Barranco, E, Claudio, J, Sosa-Padilla, M, Vazquez-Tanus, J, Velazquez-Navarro, S, Antciferov, M, Arutunov, G, Balabolkin, M, Barbarash, O, Bokarev, I, Bondar, I, Bova, E, Dreval, A, Grineva, E, Gurieva, I, Ivanova, L, Ivleva, A, Khalimov, Y, Kobalava, Z, Kotelnikov, M, Lantseva, O, Marasaev, V, Nedogoda, S, Nosova, N, Ponomareva, A, Radygina, E, Ragozin, A, Rakov, A, Rebrov, A, Reshedko, G, Reshetko, O, Rodionova, T, Rodoman, G, Ruyatkina, L, Semenova, O, Sherenkov, A, Shustov, S, Shvarts, Y, Smirnova, E, Solovyev, O, Strongin, L, Suplotova, L, Trusov, V, Vorobyev, S, Vorokhobina, N, Voychik, E, Yakusevich, V, Zagrebelnaya, O, Zalevskaya, A, Zanozina, O, Zhavoronkova, N, Zhukova, L, Bazylevych, A, Girina, O, Levchenko, O, Netiazhenko, V, Perepelytsya, M, Pertseva, T, Rudyk, Y, Slyvka, Y, Vlasenko, M, Yagensky, A, Ashley, R, Atiee, G, Bleser, SD, Bright, DK, Bueso, G, Buth, DK, Cabasares, H, Campolo, ME, Chappel, C, Conard, SE, Constantine, J, Dayon, DL, Dionne, D, Fenton, IF, Garcia, R, George, A, Gilman, R, Glaser, L, Gollapudi, M, Gray, J, Henry, WJ, Iranmanesh, A, Ison, R, Jacks, RK, Jacks, W, Jain, M, Johnson, G, Kaplan, R, Khairi, RA, LaBuda, J, LaSalle, J, Lawrence, MK, Lipetz, RS, Miller, S, Montoro, R, Mora, Y, Poindexter, A, Quigley, JF, Raad, GL, Rawtani, P, Schneider, A, Shah, S, Spence, J, Stanton, D, Sugimoto, D, Thomas, FL, Weiss, D, Weissman, P & Woodward, W 2009, 'Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: A randomized controlled trial', Diabetes, Obesity and Metabolism, vol. 11, no. 6, pp. 611-622. https://doi.org/10.1111/j.1463-1326.2009.01056.x
Jadzinsky, M. ; Pfützner, A. ; Paz-Pacheco, E. ; Xu, Z. ; Allen, E. ; Chen, Roland ; Antunez, P. ; Baccaro, C. ; Bertone, R. ; Bragagnolo, J. ; Cordo, C. S. ; Dieuzeide, G. ; Fideleff, H. L. ; Hermida, S. ; Herrera, J. ; Issa, C. ; Jadzinsky, M. ; Kraft, M. ; Maffei, L. ; Man, Z. ; Marcucci, G. ; Oviedo, A. ; Sanchez, J. M. ; Vines, G. ; Zambon, F. ; Chacra, A. ; Farias, F. ; Felicio, J. ; Forti, A. ; Gross, J. L. ; Hissa, M. N. ; Rassi, N. ; Sgarbi, J. A. ; Barakat, A. ; Böhm, G. F. ; Hanefeld, M. ; Illies, G. ; Kellner, A. ; Klausmann, G. ; Klein, C. ; Molle, A. ; Nauck, M. ; Pfützner, A. ; Sauter, J. ; Schaller, J. ; Wachter, J. ; Deák, G. ; Dudás, M. ; Foldesi, I. ; Harcsa, E. ; Salamon, C. ; Agarwal, R. P. ; Aravind, S. R. ; Dharmalingam, M. ; Jugal Bihari, G. ; Kale, S. ; Kalra, S. ; Kumar, P. ; Mahadevan, S. ; Mohan, V. ; Rao, P. ; Shah, S. ; Thomas, N. ; Wangnoo, S. K. ; Bosi, E. ; Cocchi, R. ; Cordera, R. ; Perriello, G. ; Squatrito, S. ; Arechavaleta Granell, M. D R ; Galvez Correa, G. ; Garcia Hernandez, P. A. ; Hernandez, N. ; Jerjes Sanchez, C. ; Jimenez Ramos, S. A. ; Lozano, F. ; Reyes, C. ; Robles Torres, F. J. ; Sauque Reyna, L. ; Tamez Perez, H. E. ; Velazquez, M. V. ; Villegas, E. M. ; Cimafranca, K. ; Denopol, M. ; Jimeno, C. ; Lim-Abrahan, M. ; Liwag, A. ; Panelo, A. A. ; Paz-Pacheco, E. ; Tan, G. H. ; Derezinski, T. ; Galczak, W. ; Jasieniak-Pinis, G. ; Mrozek, J. ; Petryka, R. ; Skokowska, E. ; Stasinska, T. ; Strojek, K. ; Abreu-Feshold, F. ; Barranco, E. ; Claudio, J. ; Sosa-Padilla, M. ; Vazquez-Tanus, J. ; Velazquez-Navarro, S. ; Antciferov, M. ; Arutunov, G. ; Balabolkin, M. ; Barbarash, O. ; Bokarev, I. ; Bondar, I. ; Bova, E. ; Dreval, A. ; Grineva, E. ; Gurieva, I. ; Ivanova, L. ; Ivleva, A. ; Khalimov, Y. ; Kobalava, Z. ; Kotelnikov, M. ; Lantseva, O. ; Marasaev, V. ; Nedogoda, S. ; Nosova, N. ; Ponomareva, A. ; Radygina, E. ; Ragozin, A. ; Rakov, A. ; Rebrov, A. ; Reshedko, G. ; Reshetko, O. ; Rodionova, T. ; Rodoman, G. ; Ruyatkina, L. ; Semenova, O. ; Sherenkov, A. ; Shustov, S. ; Shvarts, Y. ; Smirnova, E. ; Solovyev, O. ; Strongin, L. ; Suplotova, L. ; Trusov, V. ; Vorobyev, S. ; Vorokhobina, N. ; Voychik, E. ; Yakusevich, V. ; Zagrebelnaya, O. ; Zalevskaya, A. ; Zanozina, O. ; Zhavoronkova, N. ; Zhukova, L. ; Bazylevych, A. ; Girina, O. ; Levchenko, O. ; Netiazhenko, V. ; Perepelytsya, M. ; Pertseva, T. ; Rudyk, Y. ; Slyvka, Y. ; Vlasenko, M. ; Yagensky, A. ; Ashley, R. ; Atiee, G. ; Bleser, S. D. ; Bright, D. K. ; Bueso, G. ; Buth, D. K. ; Cabasares, H. ; Campolo, M. E. ; Chappel, C. ; Conard, S. E. ; Constantine, J. ; Dayon, D. L. ; Dionne, D. ; Fenton, I. F. ; Garcia, R. ; George, A. ; Gilman, R. ; Glaser, L. ; Gollapudi, M. ; Gray, J. ; Henry, W. J. ; Iranmanesh, A. ; Ison, R. ; Jacks, R. K. ; Jacks, W. ; Jain, M. ; Johnson, G. ; Kaplan, R. ; Khairi, R. A. ; LaBuda, J. ; LaSalle, J. ; Lawrence, M. K. ; Lipetz, R. S. ; Miller, S. ; Montoro, R. ; Mora, Y. ; Poindexter, A. ; Quigley, J. F. ; Raad, G. L. ; Rawtani, P. ; Schneider, A. ; Shah, S. ; Spence, J. ; Stanton, D. ; Sugimoto, D. ; Thomas, F. L. ; Weiss, D. ; Weissman, P. ; Woodward, William. / Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy : A randomized controlled trial. In: Diabetes, Obesity and Metabolism. 2009 ; Vol. 11, No. 6. pp. 611-622.
@article{c3dfbdb53090448e8ac3bc3ba9be55b9,
title = "Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: A randomized controlled trial",
abstract = "Aim: The study aim was to evaluate the efficacy and safety of initial combination therapy with saxagliptin + metformin vs. saxagliptin or metformin monotherapy in treatment-na{\"i}ve patients with type 2 diabetes (T2D) and inadequate glycaemic control. Methods: In this multicentre, randomized, double-blind, active-controlled phase 3 trial, 1306 treatment-na{\"i}ve patients with T2D ≥18 to ≤77 years, glycosylated haemoglobin (HbA1c) ≥8 to ≤12{\%}, fasting C-peptide concentration ≥1.0 ng/ml, body mass index ≤40 kg/m2 were randomized to receive saxagliptin 5 mg + metformin 500 mg, saxagliptin 10 mg + metformin 500 mg, saxagliptin 10 mg + placebo or metformin 500 mg + placebo for 24 weeks. From weeks 1-5, metformin was uptitrated in 500-mg/day increments to 2000 mg/day maximum in the saxagliptin 5 mg + metformin, saxagliptin 10 mg + metformin and metformin + placebo treatment groups. The main outcome measure was HbA1c change from baseline to week 24. Selected secondary outcomes included change from baseline to week 24 in fasting plasma glucose (FPG), proportion of patients achieving HbA1c",
keywords = "DPP-4, Metformin, Saxagliptin, Type 2 diabetes",
author = "M. Jadzinsky and A. Pf{\"u}tzner and E. Paz-Pacheco and Z. Xu and E. Allen and Roland Chen and P. Antunez and C. Baccaro and R. Bertone and J. Bragagnolo and Cordo, {C. S.} and G. Dieuzeide and Fideleff, {H. L.} and S. Hermida and J. Herrera and C. Issa and M. Jadzinsky and M. Kraft and L. Maffei and Z. Man and G. Marcucci and A. Oviedo and Sanchez, {J. M.} and G. Vines and F. Zambon and A. Chacra and F. Farias and J. Felicio and A. Forti and Gross, {J. L.} and Hissa, {M. N.} and N. Rassi and Sgarbi, {J. A.} and A. Barakat and B{\"o}hm, {G. F.} and M. Hanefeld and G. Illies and A. Kellner and G. Klausmann and C. Klein and A. Molle and M. Nauck and A. Pf{\"u}tzner and J. Sauter and J. Schaller and J. Wachter and G. De{\'a}k and M. Dud{\'a}s and I. Foldesi and E. Harcsa and C. Salamon and Agarwal, {R. P.} and Aravind, {S. R.} and M. Dharmalingam and {Jugal Bihari}, G. and S. Kale and S. Kalra and P. Kumar and S. Mahadevan and V. Mohan and P. Rao and S. Shah and N. Thomas and Wangnoo, {S. K.} and E. Bosi and R. Cocchi and R. Cordera and G. Perriello and S. Squatrito and {Arechavaleta Granell}, {M. D R} and {Galvez Correa}, G. and {Garcia Hernandez}, {P. A.} and N. Hernandez and {Jerjes Sanchez}, C. and {Jimenez Ramos}, {S. A.} and F. Lozano and C. Reyes and {Robles Torres}, {F. J.} and {Sauque Reyna}, L. and {Tamez Perez}, {H. E.} and Velazquez, {M. V.} and Villegas, {E. M.} and K. Cimafranca and M. Denopol and C. Jimeno and M. Lim-Abrahan and A. Liwag and Panelo, {A. A.} and E. Paz-Pacheco and Tan, {G. H.} and T. Derezinski and W. Galczak and G. Jasieniak-Pinis and J. Mrozek and R. Petryka and E. Skokowska and T. Stasinska and K. Strojek and F. Abreu-Feshold and E. Barranco and J. Claudio and M. Sosa-Padilla and J. Vazquez-Tanus and S. Velazquez-Navarro and M. Antciferov and G. Arutunov and M. Balabolkin and O. Barbarash and I. Bokarev and I. Bondar and E. Bova and A. Dreval and E. Grineva and I. Gurieva and L. Ivanova and A. Ivleva and Y. Khalimov and Z. Kobalava and M. Kotelnikov and O. Lantseva and V. Marasaev and S. Nedogoda and N. Nosova and A. Ponomareva and E. Radygina and A. Ragozin and A. Rakov and A. Rebrov and G. Reshedko and O. Reshetko and T. Rodionova and G. Rodoman and L. Ruyatkina and O. Semenova and A. Sherenkov and S. Shustov and Y. Shvarts and E. Smirnova and O. Solovyev and L. Strongin and L. Suplotova and V. Trusov and S. Vorobyev and N. Vorokhobina and E. Voychik and V. Yakusevich and O. Zagrebelnaya and A. Zalevskaya and O. Zanozina and N. Zhavoronkova and L. Zhukova and A. Bazylevych and O. Girina and O. Levchenko and V. Netiazhenko and M. Perepelytsya and T. Pertseva and Y. Rudyk and Y. Slyvka and M. Vlasenko and A. Yagensky and R. Ashley and G. Atiee and Bleser, {S. D.} and Bright, {D. K.} and G. Bueso and Buth, {D. K.} and H. Cabasares and Campolo, {M. E.} and C. Chappel and Conard, {S. E.} and J. Constantine and Dayon, {D. L.} and D. Dionne and Fenton, {I. F.} and R. Garcia and A. George and R. Gilman and L. Glaser and M. Gollapudi and J. Gray and Henry, {W. J.} and A. Iranmanesh and R. Ison and Jacks, {R. K.} and W. Jacks and M. Jain and G. Johnson and R. Kaplan and Khairi, {R. A.} and J. LaBuda and J. LaSalle and Lawrence, {M. K.} and Lipetz, {R. S.} and S. Miller and R. Montoro and Y. Mora and A. Poindexter and Quigley, {J. F.} and Raad, {G. L.} and P. Rawtani and A. Schneider and S. Shah and J. Spence and D. Stanton and D. Sugimoto and Thomas, {F. L.} and D. Weiss and P. Weissman and William Woodward",
year = "2009",
doi = "10.1111/j.1463-1326.2009.01056.x",
language = "English (US)",
volume = "11",
pages = "611--622",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "6",

}

TY - JOUR

T1 - Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy

T2 - A randomized controlled trial

AU - Jadzinsky, M.

AU - Pfützner, A.

AU - Paz-Pacheco, E.

AU - Xu, Z.

AU - Allen, E.

AU - Chen, Roland

AU - Antunez, P.

AU - Baccaro, C.

AU - Bertone, R.

AU - Bragagnolo, J.

AU - Cordo, C. S.

AU - Dieuzeide, G.

AU - Fideleff, H. L.

AU - Hermida, S.

AU - Herrera, J.

AU - Issa, C.

AU - Jadzinsky, M.

AU - Kraft, M.

AU - Maffei, L.

AU - Man, Z.

AU - Marcucci, G.

AU - Oviedo, A.

AU - Sanchez, J. M.

AU - Vines, G.

AU - Zambon, F.

AU - Chacra, A.

AU - Farias, F.

AU - Felicio, J.

AU - Forti, A.

AU - Gross, J. L.

AU - Hissa, M. N.

AU - Rassi, N.

AU - Sgarbi, J. A.

AU - Barakat, A.

AU - Böhm, G. F.

AU - Hanefeld, M.

AU - Illies, G.

AU - Kellner, A.

AU - Klausmann, G.

AU - Klein, C.

AU - Molle, A.

AU - Nauck, M.

AU - Pfützner, A.

AU - Sauter, J.

AU - Schaller, J.

AU - Wachter, J.

AU - Deák, G.

AU - Dudás, M.

AU - Foldesi, I.

AU - Harcsa, E.

AU - Salamon, C.

AU - Agarwal, R. P.

AU - Aravind, S. R.

AU - Dharmalingam, M.

AU - Jugal Bihari, G.

AU - Kale, S.

AU - Kalra, S.

AU - Kumar, P.

AU - Mahadevan, S.

AU - Mohan, V.

AU - Rao, P.

AU - Shah, S.

AU - Thomas, N.

AU - Wangnoo, S. K.

AU - Bosi, E.

AU - Cocchi, R.

AU - Cordera, R.

AU - Perriello, G.

AU - Squatrito, S.

AU - Arechavaleta Granell, M. D R

AU - Galvez Correa, G.

AU - Garcia Hernandez, P. A.

AU - Hernandez, N.

AU - Jerjes Sanchez, C.

AU - Jimenez Ramos, S. A.

AU - Lozano, F.

AU - Reyes, C.

AU - Robles Torres, F. J.

AU - Sauque Reyna, L.

AU - Tamez Perez, H. E.

AU - Velazquez, M. V.

AU - Villegas, E. M.

AU - Cimafranca, K.

AU - Denopol, M.

AU - Jimeno, C.

AU - Lim-Abrahan, M.

AU - Liwag, A.

AU - Panelo, A. A.

AU - Paz-Pacheco, E.

AU - Tan, G. H.

AU - Derezinski, T.

AU - Galczak, W.

AU - Jasieniak-Pinis, G.

AU - Mrozek, J.

AU - Petryka, R.

AU - Skokowska, E.

AU - Stasinska, T.

AU - Strojek, K.

AU - Abreu-Feshold, F.

AU - Barranco, E.

AU - Claudio, J.

AU - Sosa-Padilla, M.

AU - Vazquez-Tanus, J.

AU - Velazquez-Navarro, S.

AU - Antciferov, M.

AU - Arutunov, G.

AU - Balabolkin, M.

AU - Barbarash, O.

AU - Bokarev, I.

AU - Bondar, I.

AU - Bova, E.

AU - Dreval, A.

AU - Grineva, E.

AU - Gurieva, I.

AU - Ivanova, L.

AU - Ivleva, A.

AU - Khalimov, Y.

AU - Kobalava, Z.

AU - Kotelnikov, M.

AU - Lantseva, O.

AU - Marasaev, V.

AU - Nedogoda, S.

AU - Nosova, N.

AU - Ponomareva, A.

AU - Radygina, E.

AU - Ragozin, A.

AU - Rakov, A.

AU - Rebrov, A.

AU - Reshedko, G.

AU - Reshetko, O.

AU - Rodionova, T.

AU - Rodoman, G.

AU - Ruyatkina, L.

AU - Semenova, O.

AU - Sherenkov, A.

AU - Shustov, S.

AU - Shvarts, Y.

AU - Smirnova, E.

AU - Solovyev, O.

AU - Strongin, L.

AU - Suplotova, L.

AU - Trusov, V.

AU - Vorobyev, S.

AU - Vorokhobina, N.

AU - Voychik, E.

AU - Yakusevich, V.

AU - Zagrebelnaya, O.

AU - Zalevskaya, A.

AU - Zanozina, O.

AU - Zhavoronkova, N.

AU - Zhukova, L.

AU - Bazylevych, A.

AU - Girina, O.

AU - Levchenko, O.

AU - Netiazhenko, V.

AU - Perepelytsya, M.

AU - Pertseva, T.

AU - Rudyk, Y.

AU - Slyvka, Y.

AU - Vlasenko, M.

AU - Yagensky, A.

AU - Ashley, R.

AU - Atiee, G.

AU - Bleser, S. D.

AU - Bright, D. K.

AU - Bueso, G.

AU - Buth, D. K.

AU - Cabasares, H.

AU - Campolo, M. E.

AU - Chappel, C.

AU - Conard, S. E.

AU - Constantine, J.

AU - Dayon, D. L.

AU - Dionne, D.

AU - Fenton, I. F.

AU - Garcia, R.

AU - George, A.

AU - Gilman, R.

AU - Glaser, L.

AU - Gollapudi, M.

AU - Gray, J.

AU - Henry, W. J.

AU - Iranmanesh, A.

AU - Ison, R.

AU - Jacks, R. K.

AU - Jacks, W.

AU - Jain, M.

AU - Johnson, G.

AU - Kaplan, R.

AU - Khairi, R. A.

AU - LaBuda, J.

AU - LaSalle, J.

AU - Lawrence, M. K.

AU - Lipetz, R. S.

AU - Miller, S.

AU - Montoro, R.

AU - Mora, Y.

AU - Poindexter, A.

AU - Quigley, J. F.

AU - Raad, G. L.

AU - Rawtani, P.

AU - Schneider, A.

AU - Shah, S.

AU - Spence, J.

AU - Stanton, D.

AU - Sugimoto, D.

AU - Thomas, F. L.

AU - Weiss, D.

AU - Weissman, P.

AU - Woodward, William

PY - 2009

Y1 - 2009

N2 - Aim: The study aim was to evaluate the efficacy and safety of initial combination therapy with saxagliptin + metformin vs. saxagliptin or metformin monotherapy in treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycaemic control. Methods: In this multicentre, randomized, double-blind, active-controlled phase 3 trial, 1306 treatment-naïve patients with T2D ≥18 to ≤77 years, glycosylated haemoglobin (HbA1c) ≥8 to ≤12%, fasting C-peptide concentration ≥1.0 ng/ml, body mass index ≤40 kg/m2 were randomized to receive saxagliptin 5 mg + metformin 500 mg, saxagliptin 10 mg + metformin 500 mg, saxagliptin 10 mg + placebo or metformin 500 mg + placebo for 24 weeks. From weeks 1-5, metformin was uptitrated in 500-mg/day increments to 2000 mg/day maximum in the saxagliptin 5 mg + metformin, saxagliptin 10 mg + metformin and metformin + placebo treatment groups. The main outcome measure was HbA1c change from baseline to week 24. Selected secondary outcomes included change from baseline to week 24 in fasting plasma glucose (FPG), proportion of patients achieving HbA1c

AB - Aim: The study aim was to evaluate the efficacy and safety of initial combination therapy with saxagliptin + metformin vs. saxagliptin or metformin monotherapy in treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycaemic control. Methods: In this multicentre, randomized, double-blind, active-controlled phase 3 trial, 1306 treatment-naïve patients with T2D ≥18 to ≤77 years, glycosylated haemoglobin (HbA1c) ≥8 to ≤12%, fasting C-peptide concentration ≥1.0 ng/ml, body mass index ≤40 kg/m2 were randomized to receive saxagliptin 5 mg + metformin 500 mg, saxagliptin 10 mg + metformin 500 mg, saxagliptin 10 mg + placebo or metformin 500 mg + placebo for 24 weeks. From weeks 1-5, metformin was uptitrated in 500-mg/day increments to 2000 mg/day maximum in the saxagliptin 5 mg + metformin, saxagliptin 10 mg + metformin and metformin + placebo treatment groups. The main outcome measure was HbA1c change from baseline to week 24. Selected secondary outcomes included change from baseline to week 24 in fasting plasma glucose (FPG), proportion of patients achieving HbA1c

KW - DPP-4

KW - Metformin

KW - Saxagliptin

KW - Type 2 diabetes

UR - http://www.scopus.com/inward/record.url?scp=65549123794&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=65549123794&partnerID=8YFLogxK

U2 - 10.1111/j.1463-1326.2009.01056.x

DO - 10.1111/j.1463-1326.2009.01056.x

M3 - Article

C2 - 19515181

AN - SCOPUS:65549123794

VL - 11

SP - 611

EP - 622

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 6

ER -