Incidence of Pancreatic Malignancy and Thyroid Neoplasm in Type 2 Diabetes Mellitus Patients who Initiate Exenatide Compared to Other Antihyperglycemic Drugs - Phase 2 (Extended Accrual and Follow-Up)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24671
• EU PAS number:
  EUPAS13956
• Study ID:
  24671
• 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 - Phase 2 (Extended Accrual and Follow-Up)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort study that compares incidence rates of pancreatic cancer and thyroid neoplasm between initiators of exenatide and initiators of other antidiabetic drugs using 2 administrative databases from commercial health plans in the US. The study cohorts will be created to include patients accrued from 01 June 2005 through 30 June 2015 in Optum Research Database and 31 March 2015 in Impact National Benchmark Database. Initiators will be matched 1:1 or 1:2 (exenatide:Others) on propensity scores within 6-month calendar blocks.The matched cohorts, when aggregated, will form the analytic population. The analyses of outcomes will account for the source databases and matching ratios through statistical conditioning. Data from the 2 databases will be combined to increase statistical precision. Pancreatic cancer and thyroid neoplasm will be identified via patterns of claims using algorithms applied in the previous study. A validation of the algorithms will be conducted within a sample of medical records of patients in the Optum Research Database. Clinical characteristics that are captured poorly in the claims data will be abstracted from the medical records. Estimation of effects will involve time-fixed and time-dependent, cumulative classifications of exposure. A nested case-control analysis will also be performed to account for potential confounders that are captured poorly in the claims data, if sample size allows.
• Study status:
  Finalised

Research institution and networks

Institutions

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 24/10/2014

Actual: 24/10/2014

Study start date

Planned: 03/03/2016

Actual: 03/03/2016

Data analysis start date

Planned: 03/03/2016

Actual: 03/03/2016

Date of final study report

Planned: 01/11/2017

Actual: 17/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

Redacted protocol BO15

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)

Other study registration identification numbers and links

D5550R00003