Type 1 Diabetes Mellitus Clinical Trial
Official title:
Safety and Efficacy of Imatinib for Preserving Beta-Cell Function in New-Onset Type 1 Diabetes Mellitus
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04476472 -
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
|
N/A | |
| Completed |
NCT03635437 -
Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes
|
Phase 1/Phase 2 | |
| Completed |
NCT04909580 -
Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT00679042 -
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
|
Phase 3 | |
| Completed |
NCT03293082 -
Preschool CGM Use and Glucose Variability in Type 1 Diabetes
|
N/A | |
| Completed |
NCT04016662 -
Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)
|
Phase 4 | |
| Completed |
NCT02527265 -
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
|
Phase 2 | |
| Completed |
NCT03738865 -
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
|
Phase 3 | |
| Completed |
NCT03240432 -
Wireless Innovation for Seniors With Diabetes Mellitus
|
N/A | |
| Completed |
NCT03168867 -
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
|
N/A | |
| Completed |
NCT03674281 -
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
|
N/A | |
| Completed |
NCT03669770 -
Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
|
||
| Recruiting |
NCT03682640 -
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
|
Phase 2 | |
| Recruiting |
NCT04096794 -
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
|
||
| Completed |
NCT02882737 -
The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
|
N/A | |
| Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Completed |
NCT02558491 -
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
|
N/A | |
| Completed |
NCT02562313 -
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
|
Phase 1 | |
| Withdrawn |
NCT02518022 -
How to be Safe With Alcoholic Drinks in Diabetes
|
N/A |