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

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ClinicalTrials.gov Identifier: NCT02608853
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date October 1, 2015
First Posted Date November 20, 2015
Last Update Posted Date November 20, 2015
Study Start Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2015)
Incidence of all malignant neoplasms [ Time Frame: 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) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 17, 2015)
  • Incidence of specific malignant neoplasms - Breast (women only) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants
Official Title Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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).
Condition
  • Diabetes
  • 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.
Study Groups/Cohorts
  • Liraglutide-like Cohort
    Intervention: Other: No treatment given
  • LEADER™-like Cohort
    Intervention: Other: No treatment given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 17, 2015)
9999
Original Actual Enrollment Same as current
Actual Study Completion Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02608853
Other Study ID Numbers NN2211-4259
U1111-1173-7000 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2015