Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes
Status:
Recruiting
Trial end date:
2022-08-30
Target enrollment:
Participant gender:
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.