Clinical study for companion diagnostics for type 2 diabetes (T2DM) with aberrant tRNA modification.
Not Applicable
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000017926
- Lead Sponsor
- Dept. of Molecular Physiology and Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Recurrent severe hypoglycaemia or hypoglycaemic unawareness. 2) Liver dysfunction (AST => 100 IU/L, ALT => 100 IU/L) 3) Previous history of severe allergy to pharmaceutical products. 4) Pregnancy 5) Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator. 6) Hospitalization. 7) Treatment with prohibited drugs. 8) Prescription of Eperison within 4 weeks. 9) Patients who is taking Methocarbamol. 10) Participant of other clinical study at the screening. 11) Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of Eperizone in HbA1c changes from baseline between risk and non-risk allele groups.
- Secondary Outcome Measures
Name Time Method 1) Correlation between thiomethyl modification at A37 of tRNALys(UUU) and change in HbA1c. 2) Comparison between two groups in the folloblood glucose controlwing parameters at 12 weeks. 3) Index for blood glucose control (FBG, 1,5-AG). 4) Beta cell functions (Glucagon tolerance test, HOMA-B, proinsulin/insulin ratio) 5) Parameters for lipid metabolism (Total cholesterol, LDL-Chol, HDL-Chol, TG)