Premium
Exenatide elicits sustained glycaemic control and progressive reduction of body weight in patients with type 2 diabetes inadequately controlled by sulphonylureas with or without metformin
Author(s) -
Riddle Matthew C.,
Henry Robert R.,
Poon Terri H.,
Zhang Bei,
Mac Susanna M.,
Holcombe John H.,
Kim Dennis D.,
Maggs David G.
Publication year - 2006
Publication title -
diabetes/metabolism research and reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.307
H-Index - 110
eISSN - 1520-7560
pISSN - 1520-7552
DOI - 10.1002/dmrr.646
Subject(s) - exenatide , medicine , metformin , placebo , type 2 diabetes , weight loss , context (archaeology) , diabetes mellitus , endocrinology , gastroenterology , obesity , insulin , paleontology , alternative medicine , pathology , biology
Abstract Background In two placebo‐controlled 30‐week trials, treatment with exenatide reduced HbA 1c and body weight in patients with type 2 diabetes in the context of sulphonylurea (SU) or SU plus metformin (MET) as background treatment. This analysis examines the effects of 82 weeks of exenatide treatment for participants in these earlier 30‐week trials. Methods Data were pooled from the two pivotal trials of exenatide added to SU or SU plus MET. Both 30‐week, placebo‐controlled trials of 5 µg or 10 µg exenatide b.i.d. were followed by 52‐week open‐label, uncontrolled extension studies in which all participants received 10 µg exenatide b.i.d. and continued prior oral therapies. This interim analysis includes data for 222 patients who completed 82 weeks of exenatide treatment (61% M, age 57 ± 10 y, weight 99 ± 21 kg, BMI 34 ± 6 kg/m 2 , HbA 1c 8.4 ± 1.0% [mean ± SD]). Results Reduction in HbA 1c from baseline to week 30 (−0.8 ± 0.1% and −1.0 ± 0.1% for 5 µg b.i.d. and 10 µg b.i.d., respectively [mean ± SE]) was sustained up to week 82 (−1.0 ± 0.1%). Of 207 patients with baseline HbA 1c > 7%, 44% achieved HbA 1c ≤ 7% at week 82. Reduction of body weight from baseline to week 30 (−1.4 ± 0.3 kg and −2.1 ± 0.3 kg for 5 µg b.i.d. and 10 µg b.i.d., respectively) was progressive up to week 82 (−4.0 ± 0.3 kg). The most frequent adverse events were nausea and hypoglycaemia, both generally mild to moderate in intensity. Conclusions Exenatide added to maximally effective doses of SU or SU plus MET resulted in a sustained reduction in HbA 1c and a progressive reduction in weight over $\def\qdr#1#2{\begingroup\hbox{\raise0.3em\hbox{$\scriptstyle #1$}$\!{/}\!$\lower0.2em\hbox{$\scriptstyle #2$}}\endgroup}1\qdr{1}{2}$ years. Copyright © 2006 John Wiley & Sons, Ltd.