Clinical trial · Observational
Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants
NCT02608853CI-TRIAL-00019868completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No treatment given | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Liraglutide-like Cohort
- interventionNames
- Other: No treatment given
- label
- LEADER™-like Cohort
- interventionNames
- Other: No treatment given
Primary outcomes (1)
- measure
- Incidence of all malignant neoplasms
- timeFrame
- 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 outcomes (6)
- measure
- Incidence of specific malignant neoplasms - Breast (women only)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.