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 Bode; Robert 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

doi:10.1111/j.1463-1326.2009.01062.x

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 journal › Article › peer-review

7 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 language	English (US)
Pages (from-to)	865-873
Number of pages	9
Journal	Diabetes, Obesity and Metabolism
Volume	11
Issue number	9
DOIs	https://doi.org/10.1111/j.1463-1326.2009.01062.x
State	Published - 2009

Keywords

Antidiabetic drugs
Clinical trials
Diabetes
Glycaemic control
Repaglinide

ASJC Scopus subject areas

Internal Medicine
Endocrinology, Diabetes and Metabolism
Endocrinology

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10.1111/j.1463-1326.2009.01062.x

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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

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, Bode, B, Breakey, R, Brusco, O, Cade, J, Call, R, Chandler, J, Chaykin, L, Cheung, D, Crabtree, Y, Crockett, S, Cunnar, J, Dow, HJ, Downey, J, Drehobl, M, Dunn, L, Erman, M, Fitz-Patrick, D, Farmer, FH, Ferrera, DR, Fraser, N, Fusco, F, Garber, A, Gill, S, Gilman, R, Gilliam, J, Gollapudi, G, Hassman, D, Hutchins, R, Jain, R, Kairi, R, Kaye, W, Kawley, AF, Kayota, S, Kerzner, B, Khronusova, Y, Klonoff, D, Kumar, M, Lala, V, Landgarten, S, Lane, W, Lang, J, Lang, R, Leichter, S, Lewin, A, Lipetz, R, Littlejohn, T, Lynn, L, Madsen, D, Maggiacomo, F, Maletz, L, Malkin, S, Marple, R, McNeil, R, Messina, N, Meyers, P, Mills, R, Morawski, E, Mullen, J, O'Barr, T, Pearlstein, R, Perlman, N, Peterson, G, Pollock, J, Popeil, L, Pragalos, A, Race, J, Radin, D, Raval, P, Raskin, P, Ratner, R, Reynolds, A, Riveland, B, Colon, LR, Schwartz, S, Shusman, R, Silkiner, D, Smith, W, Snell, P, Soler, N, Snyder, B, Stringam, S, Sugimoto, D, Tamayo, R, Tanenberg, R, Touger, SM, Townsend, R, Turner, J, Weerasinghe, M, Wynne, A, Yates, S & 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, vol. 11, no. 9, pp. 865-873. https://doi.org/10.1111/j.1463-1326.2009.01062.x

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

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.",

keywords = "Antidiabetic drugs, Clinical trials, Diabetes, Glycaemic control, Repaglinide",

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

year = "2009",

doi = "10.1111/j.1463-1326.2009.01062.x",

language = "English (US)",

volume = "11",

pages = "865--873",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

publisher = "Wiley-Blackwell",

number = "9",

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TY - JOUR

T1 - Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet

AU - Raskin, Philip

AU - Lewin, A.

AU - Reinhardt, R.

AU - Lyness, W.

AU - Adler, Jay

AU - Ahmed, Azazuddin

AU - Ahmed, Khursheed

AU - Anderson, Donald

AU - Argoud, Georges

AU - Arif, Ahmed

AU - Ashinsky, Douglas

AU - Awad, Ahmed

AU - Azorr, Michael

AU - Bailey, Dwight

AU - Baker, Claire

AU - Bartilucci, Darlene

AU - Bays, Harold

AU - Bedel, Gary

AU - Bellinger, Raye

AU - Bode, Bruce

AU - Breakey, Robert

AU - Brusco, Osvaldo

AU - Cade, Jerry

AU - Call, Robert

AU - Chandler, John

AU - Chaykin, Louis

AU - Cheung, Deanna

AU - Crabtree, Yvette

AU - Crockett, Samuel

AU - Cunnar, James

AU - Dow, H. John

AU - Downey, Jackson

AU - Drehobl, Margaret

AU - Dunn, Leonard

AU - Erman, Milton

AU - Fitz-Patrick, David

AU - Farmer, Frank H.

AU - Ferrera, David R.

AU - Fraser, Neil

AU - Fusco, Frank

AU - Garber, Alan

AU - Gill, Santosh

AU - Gilman, Ronald

AU - Gilliam, John

AU - Gollapudi, Gopalakris

AU - Hassman, David

AU - Hutchins, Robert

AU - Jain, Rajeev

AU - Kairi, Rashid

AU - Kaye, William

AU - Kawley, Adam F.

AU - Kayota, Stephen

AU - Kerzner, Boris

AU - Khronusova, Yekateri

AU - Klonoff, David

AU - Kumar, Mariananda

AU - Lala, Vinod

AU - Landgarten, Steven

AU - Lane, Wendy

AU - Lang, John

AU - Lang, Robert

AU - Leichter, Steven

AU - Lewin, Andrew

AU - Lipetz, Robert

AU - Littlejohn, Thomas

AU - Lynn, Lon

AU - Madsen, Daniel

AU - Maggiacomo, Frank

AU - Maletz, Louis

AU - Malkin, Steven

AU - Marple, Richard

AU - McNeil, Robert

AU - Messina, Nicholas

AU - Meyers, Peter

AU - Mills, Richard

AU - Morawski, Emily

AU - Mullen, Julie

AU - O'Barr, Thomas

AU - Pearlstein, Robert

AU - Perlman, Neil

AU - Peterson, Gregory

AU - Pollock, Jeffrey

AU - Popeil, Larry

AU - Pragalos, Antoinette

AU - Race, James

AU - Radin, David

AU - Raval, Pramod

AU - Raskin, Philip

AU - Ratner, Robert

AU - Reynolds, Albert

AU - Riveland, Brian

AU - Colon, Luis Rivera

AU - Schwartz, Sherwyn

AU - Shusman, Robert

AU - Silkiner, David

AU - Smith, William

AU - Snell, Philip

AU - Soler, Norman

AU - Snyder, Brian

AU - Stringam, Stanley

AU - Sugimoto, Danny

AU - Tamayo, Raul

AU - Tanenberg, Robert

AU - Touger, Scott M.

AU - Townsend, Richard

AU - Turner, Jeannine

AU - Weerasinghe, Mervyr

AU - Wynne, Alan

AU - Yates, Scott

AU - Yeoman, Gary

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

KW - Antidiabetic drugs

KW - Clinical trials

KW - Diabetes

KW - Glycaemic control

KW - Repaglinide

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AN - SCOPUS:69249213686

SN - 1462-8902

VL - 11

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EP - 873

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

IS - 9

ER -

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

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Keywords

ASJC Scopus subject areas

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