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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608853
• Other study ID #: NN2211-4259
• Secondary ID: U1111-1173-7000
• Status: Completed
• Phase: N/A
• First received: October 1, 2015
• Last updated: November 17, 2015
• Start date: January 2015
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9999
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• No treatment given
No treatment is actively administered. Patients are treated according to routine clinical practice at the discretion of their treating physicians.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	No

External Links

•   Clinical Trials at Novo Nordisk