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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02733445
• Collaborator: (none)
• Enrollment: 2,650
• Duration (Months): 3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia (CML)	Drug: dasatinib; Drug: nilotinib

Study Design

• Study Type: Observational
• Actual Enrollment: 2650 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Assessment of Metabolic Outcomes Among Patients With Chronic Myelogenous Leukemia (CML) Initiating Therapy With a Tyrosine Kinase Inhibitor (TKI)
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
dasatinib cohort Patients with CML receiving dasatinib	Drug: dasatinib
nilotinib cohort Patients with CML receiving nilotinib	Drug: nilotinib

Outcome Measures

Primary Outcome Measures

1. incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population [approximately 101 months]

2. incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population [approximately 101 months]

3. incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population [approximately 101 months]

4. incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population [approximately 101 months]

5. incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population [approximately 101 months]

6. incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population [approximately 101 months]

Secondary Outcome Measures

1. incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population [approximately 101 months]

2. incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population [approximately 101 months]

3. incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population [approximately 101 months]

4. incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population [approximately 101 months]

5. risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy [approximately 101 months]

6. risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy [approximately 101 months]

7. risk comparison of developing Hyperlipidemia (HLD) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy [approximately 101 months]

8. risk comparison of developing Hyperlipidemia (HLD) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy [approximately 101 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02733445
• Other Study ID Numbers: CA180-633
• First Posted: Apr 11, 2016
• Last Update Posted: Apr 11, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Dasatinib

Study Results

No Results Posted as of Apr 11, 2016