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Completed

Type II Diabetes Mellitus in Patients Exposed to Pravastatin and Paroxetine

Incident Type II Diabetes Mellitus Among Patients Exposed to the Combination of Pravastatin and Paroxetine

Lead sponsor

GlaxoSmithKline

Assets

Exenatide / Liraglutide

Listed sites

0

Recruiting sites

Enrollment

1

actual

Study population

Key I/E criterion

Primary endpoint

Time to T2DM onset

Identifiers

Registered as

NCT IDNCT01602913
Org study ID116554
Secondary IDWEUSKOP5966GSK

Timeline

Milestones

Study first posted2012-05-21estimated
Last update posted2014-07-02estimated
Study start2011-12 (month precision)
Primary completion2012-05actual (month precision)
Study completion2012-05actual (month precision)

Assets

Investigational agents

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Data will be ascertained from the Thomson-Reuters Marketscan database, which contains administrative healthcare data among an insured population in the US between 2000 and 2009. The MarketScan® Databases capture person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, and prescription drug from a selection of large employers, health plans, and government and public organizations (MarketScan Users manual). The MarketScan Databases link 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 MarketScan Databases. These data represent the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continues and Medicare-eligible retirees with employer-provided Medicare supplemental

Inclusion criteria

patients 18 years of age or older at the index date
patients newly prescribed pravastatin or paroxetine
patients enrolled in the database for at least 180 days prior to the index date

Exclusion criteria

patients prescribed any statins, fibrates, or SRRIs other than the one defined per cohort during the duration of follow-up (in- class medication switching will result in censoring at the date of switch);
patients with T2DM or gestational diabetes ever recorded in their record
patients with impaired glucose tolerance ever recorded in their record
patients ever prescribed any oral anti-diabetic medications or insulin; or injectable GLP¬1 analogues
patients considered to have Type 1 diabetes

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Incidence of T2DM defined as having at least 2 diagnostic codes indicating T2DM after the index date, or 1 diagnostic code and 1 prescription of oral anti-diabetic medications or insulin (or Byetta and Victoza) after the index date

Time frame:Up to ten years

Time to T2DM onset

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.