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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.
Enrollment
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Inclusion criteria
Informed consent given by patients according to national regulations
Type 1 diabetes diagnosed ≥ 5 years at the time of screening
Must have been diagnosed with Type 1-diabetes before the age of 25
Age ≥18 and ≤50
Fasting c-peptide levels should be in the range from not detectable levels up to <0.12 nmol/L
For males of childbearing potential adequate contraception is as follows:
condom (male)
abstinence from heterosexual intercourse
female partner using contraception as below listed:
Exclusion criteria
Primary purpose
Allocation
Interventional model
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35 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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