Type 1 Diabetes Mellitus Clinical Trial
Official title:
Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus
The purpose of this study is to determine whether treatment with low dose cyclosporin and methotrexate can inhibit the development of new onset diabetes mellitus
Objective: Although high doses of cyclosporin (cyclo) inhibits the development of type 1
diabetes mellitus, its usefulness is limited by its toxicity. Since methotrexate (mtx) and
cyclo synergistically inhibit other disease processes, we hypothesized that low dose cyclo
and mtx therapy could safely induce remission.
Research Design and Methods: In an open pilot study, insulin dose and glycemic control will
be compared in children with new onset Type 1 diabetes administered cyclo at 7.5 mg/kg/day
for 6 weeks and then 4 mg/kg/day and mtx 5 mg/kg/day for one year with control children.
After 6 weeks, doses were adjusted to maintain blood cyclo levels to 100-200 ng/ml.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 | |
| 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 | |
| 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 |