| Literature DB >> 20518811 |
R Pencek, T Roddy, Y Peters, M B De Young, K Herrmann, L Meller, H Nguyen, S Chen, K Lutz.
Abstract
The objective of this Phase 4, open-label, multicentre, observational study was to fulfil food and drug administration (FDA) postapproval requirement to evaluate in healthcare practices the risk of insulin-induced severe hypoglycaemia following initiation of pramlintide therapy in N = 1297 patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) with inadequate glycaemic control. The duration of the study was approximately 6 months. During the adjustment period (0-3 months), the incidence and event rate of patient-ascertained severe hypoglycaemia (PASH) were 4.8% and 0.33 events/patient-year in patients with T1DM and 2.8% and 0.19 events/patient-year in patients with T2DM. During the maintenance period (>3-6 months), the incidence and event rate of PASH declined in patients with T1DM or T2DM. This study confirms that in healthcare practices, the risk of insulin-induced severe hypoglycaemia following the initiation of pramlintide is low in patients with T1DM or T2DM.Entities:
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Year: 2010 PMID： 20518811 DOI： 10.1111/j.1463-1326.2010.01201.x
Source DB: PubMed Journal: Diabetes Obes Metab ISSN： 1462-8902 Impact factor: 6.577