Premium
Addition of pramlintide to insulin therapy lowers HbA 1c in conjunction with weight loss in patients with type 2 diabetes approaching glycaemic targets
Author(s) -
Hollander P.,
Ratner R.,
Fineman M.,
Strobel S.,
Shen L.,
Maggs D.,
Kolterman O.,
Weyer C.
Publication year - 2003
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 - 10.1046/j.1463-1326.2003.00295.x
Subject(s) - medicine , placebo , insulin , diabetes mellitus , post hoc analysis , type 2 diabetes , weight loss , clinical endpoint , endocrinology , gastroenterology , clinical trial , obesity , alternative medicine , pathology
Aim: Two long‐term, randomized, double‐blind, placebo‐controlled clinical trials in insulin‐using patients with type 2 diabetes, spanning a wide range of baseline glycaemic control, have shown that the addition of pramlintide, an analogue of the β‐cell hormone amylin, to pre‐existing insulin regimens results in reductions in HbA 1c that are accompanied by weight loss. Methods: To assess whether this profile of pramlintide is observed in patients approaching, but not yet reaching, glycaemic targets, we conducted a pooled post hoc analysis of the two trials, including all patients with an entry HbA 1c between 7.0 and 8.5%. Within this subset of patients, 80 were treated with placebo + insulin [baseline HbA 1c 8.0 ± 0.3%, weight 87.3 ± 19.3 kg (mean ± s.d.)] and 86 with pramlintide (120 µg bid) + insulin [HbA 1c 8.0 ± 0.4%, weight 92.5 ± 20.4 kg (mean ± s.d.)]. Endpoints included changes from baseline to Week 26 in HbA 1c , body weight, and the event rate of severe hypoglycaemia. Results: Adjunctive therapy with pramlintide resulted in significant reductions in both HbA 1c and body weight from baseline to Week 26 (−0.43% and −2.0 kg differences from placebo, respectively, both p < 0.001). These changes were achieved without a concomitant increase in the overall rate of severe hypoglycaemic events (0.13 pramlintide vs. 0.19 placebo, events/patient year of exposure). Conclusions: The data from this post hoc analysis indicate that the addition of pramlintide to insulin therapy may help patients with type 2 diabetes who are approaching, but not yet reaching, glycaemic targets to achieve further reductions in HbA 1c without concomitant weight gain and increased risk of severe hypoglycaemia.