Clinical Trials Logo
  1. Home
  2. Type 1 Diabetes Mellitus
  3. NCT03635437

Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:
A Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients

Clinical Trial Summary

The main goal of this study is to find a reasonably safe and tolerable treatment for adult patients with type 1-diabetes and that regain some of the endogenous insulin secretion, improve the patients' quality of life (QoL) and reduce the risk of both short- and long-term complications. The hypothesis tested is that oral GABA treatment with the newly developed compound Remygen will be safe and induce regain of some endogenous insulin secretion in adult patients with type 1-diabetes diagnosis for more than five years. The first part of the study will include 6 patients and be performed as a Safety and Dose Escalation study in three steps. The main study is a three-arm, open label, single center, clinical trial. Eligible patients will be randomized into one of three active treatment arms to receive oral GABA treatment for 6 months.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03635437
Study type Interventional
Source Uppsala University Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 5, 2018
Completion date September 27, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT04476472 - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort N/A
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 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 NCT02596204 - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring 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
Completed NCT02558491 - Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM N/A