Status: Finalised First registered on: 05/07/2016
Last updated on: 28/06/2018
1. Study identification
EU PAS Register NumberEUPAS13956
Official titleIncidence 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 title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD5550R00003
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOptum
Department/Research group
Organisation/affiliationOptum
Website/Homepagehttp://www.optum.com
Details of (Primary) lead investigator
Title Dr
Last name Liang
First name Caihua
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed24/10/201424/10/2014
Start date of data collection03/03/201603/03/2016
Start date of data analysis03/03/201603/03/2016
Date of interim report, if expected
Date of final study report01/11/201717/04/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Liang
First name Caihua
Address line 11800 Concord Pike
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com 
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