Glucagon-like Peptide (GLP) Utilization and Safety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01767389
First received: January 4, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Other: The GLP-1 receptor agonist users
Other: DPP-4 inhibitor users
Other: Other ADA users

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Glucagon-like Peptide-1 (GLP-1) Agonists: Treatment Utilization Patterns and Risk of Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • For treatment utilization patterns: adherence will be assessed. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767389

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767389     History of Changes
Other Study ID Numbers: 200065, WEUSKOP6477
Study First Received: January 4, 2013
Last Updated: February 6, 2014
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
utilization
acute pancreatitis
Exenatide
DPP-4 inhibitors
liraglutide
GLP-1 receptor agonist
adherence

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Pancreatitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pancreatic Diseases
Digestive System Diseases
Glucagon
Glucagon-Like Peptide 1
Dipeptidyl-Peptidase IV Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 15, 2014