Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib

NCT ID: NCT02733445

Last Updated: 2016-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study was to determine how often and how likely patients are to develop Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy for Chronic Myelogenous Leukemia (CML).

Detailed Description

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Conditions

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Chronic Myeloid Leukemia (CML)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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dasatinib cohort

Patients with CML receiving dasatinib

dasatinib

Intervention Type DRUG

nilotinib cohort

Patients with CML receiving nilotinib

nilotinib

Intervention Type DRUG

Interventions

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dasatinib

Intervention Type DRUG

nilotinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* At least 1 prescription for nilotinib or dasatinib between 7/1/2006-12/31/2014
* Continuously enrolled in the same health plan throughout the study period
* At least 2 diagnosis codes for CML at least 30 days apart as documented in medical insurance claims

Exclusion Criteria

* patients who had a documented diagnosis of diabetes in their medical claims or received a medication for diabetes before receiving dasatinib or nilotinib
* patients who had a documented diagnosis of high cholesterol/lipids in their medical claims or received a medication for high cholesterol/lipids before receiving dasatinib or nilotinib
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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Other Identifiers

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CA180-633

Identifier Type: -

Identifier Source: org_study_id

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