Glucagon-like Peptide (GLP) Utilization and Safety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

The GLP-1 receptor agonist users

Intervention Type OTHER

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

DPP-4 inhibitor users

Intervention Type OTHER

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 ADA users

Intervention Type OTHER

Classes of ADA's other than GLP-1 receptor agonists and DPP-4 inhibitors will be included in the 'other ADA' exposure group

Interventions

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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

Intervention Type 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)

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No