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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1173-7000 | Other Identifier | WHO |
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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 LEADERâ„¢ trial participants or liraglutide initiators within the Humedica Electronic Health Record (EHR) database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide-like Cohort |
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| LEADERâ„¢-like Cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment is actively administered. Patients are treated according to routine clinical practice at the discretion of their treating physicians. |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include a cohort of patients with type 2 diabetes mellitus (T2DM) who initiated liraglutide and two cohorts of patients with T2DM standardized to have similar baseline covariates, including use of antidiabetic medicines, relative to the liraglutide initiators (the Liraglutide-like Cohort) and to participants in the LEADERâ„¢ Trial (LEADERâ„¢-like Cohort).
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Princeton | New Jersey | 08540 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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