Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | January 2015 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
