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Table 1 Summary of controlled studies included in CV analysis

From: Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

     Exenatide† Placebo or Comparator
Study/Registry Number Diabetes Management Duration* (Weeks) ITT (N) Exposure (SY) ITT (N) Exposure (SY)
DeFronzo et al, 2005 18 NCT00039013 Met 30 223 113.8 113 57.8
Buse et al, 2004 20 NCT00039026 SFU 30 254 123.2 123 55.1
Kendall et al, 2005 19 NCT00035984 Met + SFU 30 486 254.9 247 122.2
Zinman et al, 2007 24 NCT00099320 TZD ± Met 16 121 31.7 112 32.3
Kadowaki et al, 2008 27 NCT00382239 SFU ± Met 12 111 23.9 40 9.2
Gao, et al, 2009 26 NCT00324363 Met ± SFU 16 234 65.5 233 67.3
Moretto et al, 2008 28 NCT00381342 D + E 24 155 65.2 77 33.1
Gill et al, 2010 29 NCT00516074 Met and/or TZD 12 28 5.8 26 5.7
Heine et al, 2005 22 NCT00082381 Met + SFU 26 282 122.5 267 124.6
Nauck et al, 2007 23 NCT00082407 Met + SFU 52 253 220.1 248 228.6
Davis et al, 2007 25 NCT00099333 SFU or Meg and/or Met 16 33 7.7 16 5.2
Barnett et al, 2007 21 NCT00099619 Met or SFU 16‡ 136 37.3 127 38.9
Totals   -- -- 2,316 1,071.6 1,629 779.9
  1. D + E = diet and exercise therapy; ITT = Intent-to-Treat Population; Meg = meglitinide; Met = metformin; OAD = oral antidiabetic medications; SFU = sulfonylurea; TZD = thiazolidinedione
  2. *Duration of treatment with randomized study medication
  3. †Includes treatment with exenatide 2.5 mcg or 5 mcg BID for duration of study, or 4 weeks of exenatide 5 mcg BID followed by exenatide 10 mcg BID for remainder of study
  4. ‡NCT00099619 had a crossover design, with 16 weeks per period (exenatide or insulin glargine)
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Cardiovascular Diabetology

ISSN: 1475-2840