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Glucagon-like Peptide (GLP) Utilization and Safety

2014年7月31日 更新者：GlaxoSmithKline

Glucagon-like Peptide-1 (GLP-1) Agonists: Treatment Utilization Patterns and Risk of Acute Pancreatitis

This study will assess the utilization patterns (adherence, source of the index antidiabetic agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors, separately, in comparison to other ADAs.

The proposed study will help in understanding the treatment utilization patterns and the incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists. This study differs from previous observational studies by including both exenatide and liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011).

This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters) commercial health insurance database from 2005-2011.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

1

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 64年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population will include subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in Truven (Thomson Reuters) commercial health insurance database from 2005-2011. The Truven database captures person-specific clinical utilization, expenditures, and enrolment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. This databases links paid claims and encounter data to detailed patient information across sites and types of providers, and over time. The annual medical databases include private sector health data from approximately 100 payers. Historically, more than 500 million claim records are available in the database. The Commercial Claims and Encounters Database represents the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continues, and their dependents i

描述

Inclusion Criteria:

  • Subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in Truven
  • Subjects should have complete medical and pharmacy benefits and continuous enrolment in the health plan for at least 12 months before the index date (pre-index period).
  • Subjects should also have at least 1 claim of T2D diagnosis identified using ICD-9 codes 250.x0 or 250.x2 (excluding 250.x1 and/or 250.x3 - Type 1 diabetes and 648.0x - gestational diabetes)

Exclusion Criteria:

  • For the objective of evaluating the association between GLP-1 receptor agonists, DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and the use of other ADAs, subjects having evidence of pancreatic disease (ICD 9 code of 577.xx) in the pre-index period (12 months before the index date) will be excluded.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Type 2 diabetes patients taking antidiabetic agents
Subjects should also have at least 1 claim of T2D diagnosis identified using ICD-9 codes 250.x0 or 250.x2 (excluding 250.x1 and/or 250.x3 - Type 1 diabetes and 648.0x - gestational diabetes).
其他：The GLP-1 receptor agonist users
The GLP-1 receptor agonist users are classified based on the receipt of a GLP-1 receptor agonist at the index date. GLP-1 receptor agonists included in this study are exenatide and liraglutide
其他：DPP-4 inhibitor users
DPP-4 inhibitor users are classified based on the receipt of a DPP-4 inhibitor prescription at the index date. The DPP-4 inhibitors included in this study are sitagliptin, saxagliptin, linagliptin, combination of sitagliptin and metformin (Janumet), and combination of sitagliptin and simvastatin (Juvisync)
其他：Other ADA users
Classes of ADA's other than GLP-1 receptor agonists and DPP-4 inhibitors will be included in the 'other ADA' exposure group

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
For treatment utilization patterns: adherence will be assessed.
大体时间：6 years
For acute pancreatitis: the study outcome will be the first incidence of acute pancreatitis identified by the ICD-9 code of 577.0 listed as a primary discharge diagnosis on a hospitalization claim. Adherence to GLP-1 receptor agonists, DPP-4 inhibitors and other ADAs will be measured by Medication Possession Ratio (MPR). MPR will be calculated at the class-level for each of the classes of ADA until one of the censoring events.
6 years
For treatment utilization patterns: source of the index ADA (add-on, switch or new therapy) will be assessed.
大体时间：6 years
6 years
For treatment utilization patterns: treatment modification (discontinuation of the index ADA, switching of the index and concomitant ADA, and add-on therapy) will be assessed.
大体时间：6 years
6 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年9月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2013年1月4日

首先提交符合 QC 标准的

2013年1月10日

首次发布 (估计)

2013年1月14日

研究记录更新

最后更新发布 (估计)

2014年8月4日

上次提交的符合 QC 标准的更新

2014年7月31日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 200065
  • WEUSKOP6477 (其他标识符：GSK)

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