Type 2 diabetes mellitus
Conditions
Interventions
1) Cdkal1 homo risk allele Eperisone (50 mg tablet), 1 Tab. po, TID for 12 weeks.
2) Cdkal1 hetero non-risk allele Eperisone (50 mg tablet), 1 Tab. po, TID for 12 weeks.
3) Homo non-risk allele Epe
Sponsors
Dept. of Molecular Physiology and Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with type 2 diabetes. 2) Age 20 - 75 y.o. 3) Type 2 diabetes patients with mono or combination therapy of following OHA - SU, Glinides, a-GI, Biguanides, Thiazolidinedione, or DPP-4 inhibitors. 4) HbA1c 6.2 - 8.5% 5) HbA1c change <= 1.0% with no alteration of treatment for 3 months prior to the day of screening. 6) Females who sign for contraception, if capable of pregnancy. 7) Patients with adequate understanding and/or cooperation as judged by the Investigator 8) Patients with written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Eperizone in HbA1c changes from baseline between risk and non-risk allele groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactTakafumi Senokuchi
Faculty of Life Sciences, Kumamoto University Department of Molecular Diabetology
Outcome results
None listed