Type 1 diabetes MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Remygen
Product Code: ?-aminobutyric Acid (GABA)
Pharmaceutical Form: Tablet
Trade Name: Alprazolam Orion 0,5 mg
Product
Sponsors
Uppsala University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent given by patients according to national regulations 2. Type 1 diabetes diagnosed = 5 years at the time of screening 3. Must have been diagnosed with Type 1-diabetes before the age of 25 4. Age =18 and =50 5. Fasting c-peptide levels should be in the range from not detectable levels up to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Females of child-bearing potential 2. Previous or current treatment with immunosuppressant therapy (although topical and inhalation steroids are accepted) 3. Treatment with any oral or injected anti-diabetic medications other than insulin 4. Patients on medications which may disturb GABA action, such as Baclofen, Valium, Acamprosate, Neurontin, or Lyrica 5. HbA1c > 90 mmol/mol 6. eGFR 0.75 µkatl/l for females or >1.1 µkat/l for males) and/or aspartate aminotransferase (>0.60 µkat/l for females or >0.75µkat/l for males). 8. Known cancer disease 9. Known sleeping apnea or pulmonary disorder with carbon dioxide retention in blood 10. Previous history of pancreatitis or other exocrine pancreatic disorder 11. A history of epilepsy, myasthenia gravis, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles 12. A history of alcohol or drug abuse 13. A significant illness other than diabetes within 2 weeks prior to first dosing 14. Known human immunodeficiency virus (HIV) or hepatitis 15. Females who are breastfeeding 16. Males not willing to use adequate contraception during the study period. 17. Known hypersensitivity against benzodiazepins or any excipients of study drugs 18. Participation in other clinical trials with a new chemical entity within 3 months or 5 half-lives of the new chemical entity, whatever longest. 19. Inability or unwillingness to comply with the provisions of this protocol 20. Deemed by the investigator not being able to follow instructions and/or follow the study protocol or other reasons that, at the investigator’s discretion, could affect the subject’s current clinical condition during study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the acute and long-term safety of oral GABA treatment.;Secondary Objective: The secondary objectives are to evaluate the different effect between the three treatment groups. As well as to analyze the outcome of oral GABA treatment, with or without combination with alprazolam treatment, on regaining endogenous insulin secretion as measured by C-peptide, overall diabetes status, serum levels of GABA, effects on the immune system and quality of life (QoL) of the patients (using the DTSQ and RAND-36 questionnaires).; Primary end point(s): • Number of AEs/SAEs possibly or probably related to GABA treatment or GABA treatment in combination with Alprazolam • Changes in laboratory parameters, physical examinations and vital signs over time vs baseline values ; Timepoint(s) of evaluation of this end point: After 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: After 3 and 6 months of treatment and at follow up (1 month after end of treatment).; Secondary end point(s): • Difference in C-peptide (Area Under the Curve [AUC]mean 0-120 min) during a Mixed Meal Tolerance Test (MMTT) between baseline and after 3 months of treatment, 6 months of treatment and the follow-up visit respectively for all treatments (Low dose daily oral GABA treatment, High dose daily oral GABA treatment, High dose oral GABA in combination with Alprazolam treatment). • Difference in C-peptide (Area Under the Curve [AUC]mean 0-120 min) during an MMTT between baseline and after 3 months of treatment, 6 months of treatment and the follow-up visit respectively for all treatments. Analyzed with an ultra-sensitive ELISA. • Difference in maximum stimulated C-peptide during an MMTT between baseline and after 3 months of treatment, 6 months of treatment and the follow-up visit respectively for all treatments. • Difference in maximum stimulated C-peptide during an MMTT between baseline and after 3 months of treatment, 6 months of treatment and the follow-up visit respectively for all treatments. Analyzed with an ultra-sensitive ELISA. • Difference between the treatments in difference in C-peptide (Area Under the Curve [AUC]mean 0-120 min) during an MMTT between baseline and after 3 months of treatment, 6 months of treatment and the follow-up visit. • Difference in glucagon (Area Under the Curve [AUC]mean 0-120 min) during an Hypoglycemic Clamp between baseline and 6 months of treatment for all treatments. • Difference between treatments in difference in glucagon (Area Under the Curve [AUC]mean 0-120 min) during an Hypoglycemic Clamp between baseline and 6 months of treatment. • Variables that indicate diabetes status such as plasma C-peptide, glucagon, proinsulin, proinsulin/C-peptide, gluca | — |
Countries
Sweden
Contacts
Public ContactPer-Ola Carlsson
Uppsala University Hospital
Outcome results
None listed