| Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational study. | |
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MedLine Citation:
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PMID: 20518811 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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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. |
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Authors:
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R Pencek; T Roddy; Y Peters; M B De Young; K Herrmann; L Meller; H Nguyen; S Chen; K Lutz |
Publication Detail:
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Type: Letter; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Diabetes, obesity & metabolism Volume: 12 ISSN: 1463-1326 ISO Abbreviation: Diabetes Obes Metab Publication Date: 2010 Jun |
Date Detail:
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Created Date: 2010-06-03 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100883645 Medline TA: Diabetes Obes Metab Country: England |
Other Details:
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Languages: eng Pagination: 548-51 Citation Subset: IM |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00229658 |
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Descriptor/Qualifier:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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