Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet

Philip Raskin, A. Lewin, R. Reinhardt, W. Lyness, Jay Adler, Azazuddin Ahmed, Khursheed Ahmed, Donald Anderson, Georges Argoud, Ahmed Arif, Douglas Ashinsky, Ahmed Awad, Michael Azorr, Dwight Bailey, Claire Baker, Darlene Bartilucci, Harold Bays, Gary Bedel, Raye Bellinger, Bruce BodeRobert Breakey, Osvaldo Brusco, Jerry Cade, Robert Call, John Chandler, Louis Chaykin, Deanna Cheung, Yvette Crabtree, Samuel Crockett, James Cunnar, H. John Dow, Jackson Downey, Margaret Drehobl, Leonard Dunn, Milton Erman, David Fitz-Patrick, Frank H. Farmer, David R. Ferrera, Neil Fraser, Frank Fusco, Alan Garber, Santosh Gill, Ronald Gilman, John Gilliam, Gopalakris Gollapudi, David Hassman, Robert Hutchins, Rajeev Jain, Rashid Kairi, William Kaye, Adam F. Kawley, Stephen Kayota, Boris Kerzner, Yekateri Khronusova, David Klonoff, Mariananda Kumar, Vinod Lala, Steven Landgarten, Wendy Lane, John Lang, Robert Lang, Steven Leichter, Andrew Lewin, Robert Lipetz, Thomas Littlejohn, Lon Lynn, Daniel Madsen, Frank Maggiacomo, Louis Maletz, Steven Malkin, Richard Marple, Robert McNeil, Nicholas Messina, Peter Meyers, Richard Mills, Emily Morawski, Julie Mullen, Thomas O'Barr, Robert Pearlstein, Neil Perlman, Gregory Peterson, Jeffrey Pollock, Larry Popeil, Antoinette Pragalos, James Race, David Radin, Pramod Raval, Philip Raskin, Robert Ratner, Albert Reynolds, Brian Riveland, Luis Rivera Colon, Sherwyn Schwartz, Robert Shusman, David Silkiner, William Smith, Philip Snell, Norman Soler, Brian Snyder, Stanley Stringam, Danny Sugimoto, Raul Tamayo, Robert Tanenberg, Scott M. Touger, Richard Townsend, Jeannine Turner, Mervyr Weerasinghe, Alan Wynne, Scott Yates, Gary Yeoman

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Aim: To assess the use of a new repaglinide/metformin fixed-dose combination (FDC) tablet for the treatment of type 2 diabetes. Methods: In this 26-week, multicentre, open-label, parallel-group trial, subjects poorly controlled with mono- or dual-oral antidiabetic therapy were randomized 1: 1: 1 to receive a repaglinide/metformin FDC tablet either two times daily (BID) or three times daily (TID) or a rosiglitazone/metformin FDC tablet BID. The primary objective comprised two hypotheses tested in a hierarchical order: (i) that treatment with the repaglinide/metformin FDC BID is non-inferior to that of a rosiglitazone/metformin FDC tablet BID as measured by changes in haemoglobin A1c (HbA1c) (results presented here) and (ii) if true, that treatment with the repaglinide/metformin FDC BID was non-inferior to that of the repaglinide/metformin FDC TID as measured by changes in HbA1c (results presented in a companion paper). Additional efficacy and safety end-points were also assessed. Results: Of the 561 subjects randomized, 383 completed the study. Reductions in HbA1c values became apparent at earlier times for repaglinide/metformin FDC BID treatment than rosiglitazone/metformin FDC BID, and final changes in HbA1c were not significantly different between treatment arms (p = 0.8186); thus, the predefined statistical criterion for non-inferiority was met. Overall adverse event profiles were comparable between treatment groups, and no major hypoglycaemic episodes were reported during the study. Conclusions: The repaglinide/metformin FDC BID regimen showed efficacy that was non-inferior to that of the rosiglitazone/metformin FDC BID regimen currently in clinical use and a more rapid reduction of HbA1c values. Thus, repaglinide/metformin FDC BID is a clinically feasible alternative to rosiglitazone/metformin FDC BID.

Original languageEnglish (US)
Pages (from-to)865-873
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume11
Issue number9
DOIs
StatePublished - Jan 1 2009

    Fingerprint

Keywords

  • Antidiabetic drugs
  • Clinical trials
  • Diabetes
  • Glycaemic control
  • Repaglinide

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Raskin, P., Lewin, A., Reinhardt, R., Lyness, W., Adler, J., Ahmed, A., Ahmed, K., Anderson, D., Argoud, G., Arif, A., Ashinsky, D., Awad, A., Azorr, M., Bailey, D., Baker, C., Bartilucci, D., Bays, H., Bedel, G., Bellinger, R., ... Yeoman, G. (2009). Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet. Diabetes, Obesity and Metabolism, 11(9), 865-873. https://doi.org/10.1111/j.1463-1326.2009.01062.x