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Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes
Author(s) -
Blonde L.,
Klein E. J.,
Han J.,
Zhang B.,
Mac S. M.,
Poon T. H.,
Taylor K. L.,
Trautmann M. E.,
Kim D. D.,
Kendall D. M.
Publication year - 2006
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2006.00602.x
Subject(s) - exenatide , medicine , type 2 diabetes , placebo , weight loss , metformin , body mass index , population , clinical endpoint , interim analysis , overweight , adverse effect , discontinuation , diabetes mellitus , randomized controlled trial , insulin , obesity , endocrinology , alternative medicine , environmental health , pathology
Aim: Exenatide, an incretin mimetic for the adjunct treatment of type 2 diabetes (DM2), reduced A1C and weight in 30‐week placebo‐controlled trials. This analysis examined the effects of exenatide on glycaemic control and weight over an 82‐week period in patients with DM2 unable to achieve adequate glycaemic control with sulphonylurea (SU) and/or metformin (MET). Methods: This interim analysis is of 314 patients who received exenatide in the 30‐week placebo‐controlled trials and subsequently in 52 weeks of open‐label uncontrolled extension studies for 82 weeks of exenatide in total. Patients continued their SU and/or MET regimens throughout. Results: Patients completed 82 weeks of exenatide treatment [n = 314, 63% M, age 56 ± 10 years, weight 99 ± 21 kg, body mass index 34 ± 6 kg/m 2 , A1C 8.3 ± 1.0% (mean ± SD)]. Reduction in A1C from baseline to week 30 [−0.9 ± 0.1% (mean ± SE)] was sustained to week 82 (−1.1 ± 0.1%), with 48% of patients achieving A1C ≤ 7% at week 82. At week 30, exenatide reduced body weight (a secondary endpoint) from baseline (−2.1 ± 0.2 kg), with progressive reduction at week 82 (−4.4 ± 0.3 kg). Similar results were observed for the intent‐to‐treat population (n = 551), with reductions in A1C and weight at week 82 of −0.8 ± 0.1% and −3.5 ± 0.2 kg respectively. The 82‐week completer cohort showed statistically significant improvement in some cardiovascular risk factors. The most frequent adverse events were generally mild‐to‐moderate nausea and hypoglycaemia. Conclusion: In summary, 82 weeks of adjunctive exenatide treatment in patients with DM2 treated with SU and/or MET resulted in sustained reduction in A1C and progressive reduction in weight, as well as improvement in some cardiovascular risk factors.