Glucagon-like Peptide (GLP) Utilization and Safety
|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|
|Primary Completion Date :||December 2013|
|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 liraglutideOther: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767389
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|