Glucagon-like Peptide (GLP) Utilization and Safety
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|ClinicalTrials.gov Identifier: NCT01767389|
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : August 4, 2014
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.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Other: The GLP-1 receptor agonist users Other: DPP-4 inhibitor users Other: Other ADA users|
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Glucagon-like Peptide-1 (GLP-1) Agonists: Treatment Utilization Patterns and Risk of Acute Pancreatitis|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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).
Other: 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
Other: 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)
Other: 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
- For treatment utilization patterns: adherence will be assessed. [ Time Frame: 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.
- For treatment utilization patterns: source of the index ADA (add-on, switch or new therapy) will be assessed. [ Time Frame: 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. [ Time Frame: 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767389
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|