Trials / Completed
CompletedNCT01781975
Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus
Safety and Efficacy of Imatinib for Preserving Beta-Cell Function in New-Onset Type 1 Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Eligible participants will be randomized to receive either imatinib mesylate or placebo daily. All participants randomized into this study will be seen at a study site for a follow-up evaluation, 2 weeks and 4 weeks after randomization, and every month month thereafter for the first year. Participants will come in for a visit ever 6 months for the second year. At the study visits, participants will undergo assessments of their insulin production, immunologic status, and overall health. Subjects will be followed until the conclusion of the study. The trial is expected to last approximately 2-4 years or until the required amount of information is gathered.
Conditions
- Diabetes Mellitus, Type I
- Diabetes Mellitus, Insulin-Dependent, 1
- Type 1 Diabetes Mellitus
- Insulin-Dependent Diabetes Mellitus 1
- IDDM
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Imatinib Mesylate | |
| DRUG | Placebo (For imatinib mesylate) |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2017-05-01
- Completion
- 2018-05-01
- First posted
- 2013-02-01
- Last updated
- 2020-02-11
- Results posted
- 2018-08-08
Locations
9 sites across 2 countries: United States, Australia
Source: ClinicalTrials.gov record NCT01781975. Inclusion in this directory is not an endorsement.