Table 1.
Overview of Exenatide Phase 3 Clinical Trial Designs.
| Study Citation | Study Dur (wk) | Double Blind? | Multi-National? (#countries) | Analysis Pop | Mean Calc | NCT#a |
|---|---|---|---|---|---|---|
| Exenatide BID | ||||||
| Bergenstal 2009 [86] | 24 | No | No (US) | ITT & per protocol | Mean | 00097877 |
| Blonde 2006 [87] | 82 | No | No (US) | ITT & completers | Mean | 00111540 |
| Bunck 2009 [88] | 52 | No | Yes (3) | ITT & evaluable | Mean | 00097500 |
| Bunck 2011 [89] | 168 | No | Yes (3) | ITT & evaluable | Mean | 00097500 |
| Buse 2011 [90] | 30 | Yes | Yes (5) | ITT | LS Mean | 00765817 |
| Buse 2009 [91] | 26 | No | Yes (15) | ITT & per protocol | LS Mean | 00518882 |
| Buse 2004 [92] | 30 | Yes | No (US) | ITT & evaluable | Mean | 00039026 |
| Buse 2007 [93] | 104 | No | No (US) | ITT & completers | Mean | 00111540 |
| Davies 2009 [94] | 26 | No | No (UK) | ITT | LS Mean | 00360334 |
| DeFronzo 2005 [95] | 30 | Yes | No (US) | ITT & evaluable | Mean | 00039013 |
| Derosa 2010 [96] | 52 | No | No (Italy) | ITT | Mean | NA |
| Derosa 2011 [97] | 52 | No | No (Italy) | ITT | Mean | NA |
| Forti 2008 [98] | 12 | No | Yes (2) | Per protocol | LS Mean | 00359879 |
| Gallwitz 2011 [99] | 26 | No | No (Germany) | ITT | LS Mean | 00434954 |
| Gao 2009 [100] | 16 | Yes | Yes (4) | ITT & per protocol | LS Mean | 00324363 |
| Gill 2010 [101] | 12 | Yes | Yes (2) | ITT & per protocol | LS Mean | 00516074 |
| Heine 2005 [102] | 26 | No | Yes (13) | ITT & per protocol | LS Mean | 00082381 |
| Kadowaki 2009 [103] | 12 | Yes | No (Japan) | ITT | Mean | 00382239 |
| Kadowaki 2011 [104] | 24 | Yes | No (Japan) | ITT | LS Mean | 00577824 |
| Kendall 2005 [105] | 30 | Yes | No (US) | ITT & evaluable | Mean | 00035984 |
| Klonoff 2008 [106] | 156 / 182 | No | No (US) | ITT & completers | Mean | 00111540 |
| Liukus 2010 [107] | 26 | Yes | Yes (5) | ITT | LS Mean | 00603239 |
| Moretto 2008 [108] | 24 | Yes | Yes (4) | ITT | LS Mean | 00381342 |
| Nauck 2007 [109] | 52 | No | Yes (13) | ITT & per protocol | Mean | 00082407 |
| Ratner 2006 [110] | 82 | No | No (US) | ITT & completers | Mean | 00111540 |
| Riddle 2006 [111] | 82 | No | No (US) | ITT & completers | Mean | 00111540 |
| Zinman 2007 [112] | 16 | Yes | Yes (3) | ITT & per protocol | LS Mean | 00099320 |
| Exenatide QW | ||||||
| Bergenstal 2010 [113] | 26 | Yes | Yes (3) | ITT & evaluable | LS Mean | 00637273 |
| Blevins 2011 [114] | 24 | No | No (US) | ITT & evaluable | LS Mean | 00877890 |
| Buse 2010 [115] | 52 | No | Yes (2) | ITT & evaluable | LS & Geo Mean | 00308139 |
| Buse 20111 | 26 | No | Yes (21) | ITT | LS Mean | 01029886 |
| Diamant 2010 [116] | 26 | No | Yes (15) | ITT | LS Mean | 00641056 |
| Drucker 2008 [117] | 30 | No | Yes (2) | ITT & evaluable | LS & Geo Mean | 00308139 |
| MacConell 20112 | 156 | No | Yes (2) | Completers | LS & Geo Mean | 00308139 |
| Russell-Jones 2012 [118] | 26 | Yes | Yes (22) | ITT | LS Mean | 00676338 |
| Taylor 2011 [119] | 104 | No | Yes (2) | ITT & Completers | LS Mean | 00308139 |
| Wysham 2011 [120] | 52 | No | Yes (3) | Evaluable | LS Mean | 00637273 |
a
Additional information on these trials is available at clinicaltrials.gov
Abbreviations: BID, twice daily; Dur, duration; Geo, geometric; ITT, intent-to-treat; LS, least squares; NA, not applicable; NCT, national clinical trial database; NI, non-inferiority; Pop, population; QW, once weekly; ΔRx, change or different diabetes medication prior to randomization; S, superiority.