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, W. R. Woodward

Research output: Contribution to journalArticle

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
Pages (from-to)611-622
Number of pages12
JournalDiabetes, Obesity and Metabolism
Volume11
Issue number6
DOIs
Publication statusPublished - 2009

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

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    Jadzinsky, M., Pfützner, A., Paz-Pacheco, E., Xu, Z., Allen, E., Chen, R., 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., ... Woodward, W. R. (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, 11(6), 611-622. https://doi.org/10.1111/j.1463-1326.2009.01056.x