Clinical trial · Observational
Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib
Assessment of Metabolic Outcomes Among Patients With Chronic Myelogenous Leukemia (CML) Initiating Therapy With a Tyrosine Kinase Inhibitor (TKI)
NCT02733445CI-TRIAL-00021690completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- label
- dasatinib cohort
- description
- Patients with CML receiving dasatinib
- interventionNames
- Drug: dasatinib
- label
- nilotinib cohort
- description
- Patients with CML receiving nilotinib
- interventionNames
- Drug: nilotinib
Primary outcomes (6)
- measure
- 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
- timeFrame
- approximately 101 months
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.