Study identification

EU PAS number

EUPAS3614

Study ID

20439

Official title and acronym

Incidence of Pancreatic Malignancy and Thyroid Neoplasm in Type 2 Diabetes Mellitus Patients who Initiate Exenatide Compared to Other Antihyperglycemic Drugs. (B015)

DARWIN EU® study

No

Study countries

United States

Study description

The purpose of this study was to assess incident pancreatic and thyroid cancers among patients who initiated exenatide as compared to patients who initiated other second line use antidiabetes drugs. This was a large population-based retrospective cohort study using data from two large administrative databases in the United States from 2005 to 2010. Medical chart validated claims based algorithms were used to identify incident outcomes. Outcomes were assessed starting one-year post index drug exposure. Propensity score matching and multivariate modeling were used to adjust for cohort differences. After selection criteria, there were 18,932 initiators of exenatide and 27,691 matched initiators of other antihyperglycemic drugs across both databases, with a total of 10 and 11 pancreatic cancer cases and 16 and 16 thyroid cancer cases, respectively. For pancreatic cancer there was no significant difference between study cohorts in either database assessed (HR=1.4, 95%CI=0.4-4.2, HR=0.8, 95%CI=0.2-3.6). For thyroid cancer, results were also non-significant in both databases (HR=2.0, 95%CI=0.7-5.6, HR=1.3, 95%CI=0.5-3.4). Additional analyses were conducted stratifying by follow-up time, exposure duration, and cumulative dose. Given the small numbers in several fo these strata, no conclusions were made regarding this data. In conclusion, these analyses do not support nor refute the presence of an increased incidence of pancreatic or thyroid cancers amogn exenatide initiators when compared to other antihyperglycemic drugs initiators. There were differences in the direction and strength of point estimates between the two different databases. Determining the underlying reasons (e.g., chance, unmeasured confounding, detection bias, and/or protopathic bias) for variability is challenging given the small number of outcomes observed.

Study status

Finalised
Research institutions and networks

Institutions

Optum
Germany
First published:
07/02/2014
Institution Outdated Other ENCePP partner

Contact details

Stephen Motsko

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)