type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes mellitus and/or postprandial hyperglycemia 1. Not good glycemic control after diet and excise regimen and requires medical treatment 2. Aged 20 -79 years old 3. Males and females 4. HbA1c (NGSP) <9.0% 5. Provided written informed consent before any trial related activities commence
Exclusion criteria
Exclusion criteria: 1. Hypoglycemia unawareness or recurrent major hypoglycaemia 2. Known severe liver disease 3. Known or suspected allergy to trial products or related products 4. Pregnant or planning to become pregnant within the next 12 months, breast-feeding 5. Any condition that the Investigator or Sponsor feel would interfere with trial participation or evaluation of results 6. Not provided written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| continuous glucose monitor (CGM) marker, flow-mediated di;atation (FMD) | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c, 1,5-AG, 8isoPGF2a, TBARS, total, LDL. HDL cholesterol triglyceride MDL and RLP cholesterol, AST ALT g-GTP LDH, BUN creatinine, cystatin C, urinary albumin excretion | — |
Countries
Japan
Contacts
The University of Tokushima Graduate School of Health Biosciences Department of Cardio-Diabetes Medicine