Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants

Study Overview
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Brief Summary
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This study is conducted in the United States of America. The aim of this study is to estimate incidence rates of all malignant neoplasms, specific subgroups of malignant neoplasms, and acute pancreatitis among cohorts of antidiabetic drug users standardized to be representative of LEADER™ trial participants or liraglutide initiators within the Humedica Electronic Health Record (EHR) database.

Official Title
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Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: No treatment given


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Cohort Members: Members of each of the cohorts must have at least 12 months of baseline coverage within Humedica prior to the patients' index date (cohort- specific index dates are defined below). Within Humedica, baseline coverage will be defined as the date from the earliest observed encounter up to and including the index date. Patients must have at least 1 diagnosis of T2DM (250.X0 or 250.X2) prior to and including the date of the qualifying prescription, no prior diagnosis (inclusive of the index date) of T1DM (250.X1 or 250.X3) and no diagnosis of gestational diabetes within the previous 12 months (inclusive of the index date). Patients will not be eligible for inclusion if they have prior prescriptions for GLP-1 analogues (including liraglutide and exenatide) during the interval that would be considered the baseline period Liraglutide-like Cohort: To be eligible for inclusion in the Liraglutide-like Cohort, patients must have at least one qualifying prescription for an OAD. Qualifying OADs will be specified that share similar labelled or unlabelled indications as liraglutide LEADER™-like Cohort: To be eligible for inclusion in the LEADERTM-like Cohort, patients must meet the following inclusion and exclusion criteria: Patients will be eligible for inclusion after meeting the overall inclusion and exclusion criteria in addition to the following: Ages 50 and over. HbA1c at least 7% Exclusion Criteria: Patients will be excluded from the LEADER™-like Cohort if any of the following are observed prior to meeting the inclusion criteria defined above: Calcitonin >= 50ng/L. Baseline DPP-4 or pramlintide. Chronic heart failure diagnosis, NYHA Class IV. Acute coronary or cerebrovascular event within 14 days prior to initiation. Current continuous renal replacement therapy. End-stage liver disease. Solid organ transplant. Malignant neoplasm
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide-like Cohort<br> | Other: No treatment given<br>* No treatment is actively administered. Patients are treated according to routine clinical practice at the discretion of their treating physicians.<br>|
| LEADER™-like Cohort<br> | Other: No treatment given<br>* No treatment is actively administered. Patients are treated according to routine clinical practice at the discretion of their treating physicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all malignant neoplasms |  | Follow-up is defined as the period following the date of the qualifying prescription or diagnosis (01 Jan 2008 at the earliest) and will vary depending on when this date occurs. The follow-up study period ends on 31 Dec 2013 (in total up to 6 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of specific malignant neoplasms - Breast (women only) |  | Follow-up is defined as the period following the date of the qualifying prescription or diagnosis (01 Jan 2008 at the earliest) and will vary depending on when this date occurs. The follow-up study period ends on 31 Dec 2013 (in total up to 6 years) | 
| Incidence of specific malignant neoplasms - Colorectal |  | Follow-up is defined as the period following the date of the qualifying prescription or diagnosis (01 Jan 2008 at the earliest) and will vary depending on when this date occurs. The follow-up study period ends on 31 Dec 2013 (in total up to 6 years) | 
| Incidence of specific malignant neoplasms - Pancreatic |  | Follow-up is defined as the period following the date of the qualifying prescription or diagnosis (01 Jan 2008 at the earliest) and will vary depending on when this date occurs. The follow-up study period ends on 31 Dec 2013 (in total up to 6 years) | 
| Incidence of specific malignant neoplasms - Thyroid |  | Follow-up is defined as the period following the date of the qualifying prescription or diagnosis (01 Jan 2008 at the earliest) and will vary depending on when this date occurs. The follow-up study period ends on 31 Dec 2013 (in total up to 6 years) | 
| Incidence of specific malignant neoplasms - Medullary Thyroid |  | Follow-up is defined as the period following the date of the qualifying prescription or diagnosis (01 Jan 2008 at the earliest) and will vary depending on when this date occurs. The follow-up study period ends on 31 Dec 2013 (in total up to 6 years) | 
| Incidence of acute pancreatitis |  | Follow-up is defined as the period following the date of the qualifying prescription or diagnosis (01 Jan 2008 at the earliest) and will vary depending on when this date occurs. The follow-up study period ends on 31 Dec 2013 (in total up to 6 years) |