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Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus

NCT01781975 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-02-11

Study results available
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Summary

Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing ß cells. Although exogenous insulin is widely available, it is not possible for affected individuals to consistently achieve euglycemia with current technology, and thus they are at risk for devastating long-term complications. This phase II study is designed to evaluate the safety and efficacy of imatinib mesylate as a novel therapy for new-onset T1DM. Imatinib is a first-in-class tyrosine kinase inhibitor.

This study will explore the potential role of short-term therapy with imatinib to induce tolerance and possibly lead to a durable long-term remission of T1DM.

Conditions

  • Diabetes Mellitus, Type I
  • Diabetes Mellitus, Insulin-Dependent, 1
  • Type 1 Diabetes Mellitus
  • Insulin-Dependent Diabetes Mellitus 1
  • IDDM

Interventions

DRUG

Imatinib Mesylate

DRUG

Placebo (For imatinib mesylate)

Sponsors & Collaborators

Principal Investigators

  • Stephen E Gitelman, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-05-31
Completion
2018-05-31

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781975 on ClinicalTrials.gov