NCT02608853

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

Same day

First QC Date

October 1, 2015

Last Update Submit

November 17, 2015

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

Liraglutide-like Cohort

Other: No treatment given

LEADER™-like Cohort

Other: No treatment given

Interventions

No treatment givenOTHER

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

LEADER™-like CohortLiraglutide-like Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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 LEADER™ Trial (LEADER™-like Cohort).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, 08540, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

November 20, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

US(1)