type2 diabetes
Conditions
Interventions
Check the blood glucose levels by self-monitoring nine times totally
three times in a day for observation period and administration period of Glufast or Glubes combination tablets.Take blood and urine sample and do a meal tolerance test at the clinic for each three per
Sponsors
Advanced Clinical Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients only treated by diet and exercise therapy, or patients treated by oral hypoglycemic agents except SU or insulin who can have washout periods with those agents for more than four weeks 2) Possible to take the test meal (a set of Chicken in white sauce, crackers, soft pudding) 3) Over 20 years old 4) Voluntarily signed to the consent form after taking enough explanation of the significance and the objectives of this study
Exclusion criteria
Exclusion criteria: 1) Patients who are applicable to the [taboo issue] in a package insert of Glubes combination tablets. Patients who have severe ketosis, precoma or diabetic coma or type 1 diabetes. Patients with severe infection or severe injury. Patients accepting surgery. Patients with a history of hypersensitivity to any component of this drug. Pregnant women and women suspected to be pregnant. 2) Patients whom the principal investigator and investigators decided not to be appropriate for taking Glubes combination tablets, on the point of [Special caution needed] and [side effects] in the package insert.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints:Blood glucose levels by SMBG. Amounts and changing value of blood glucose, insulin, proinsulin, C-peptide, glucagon, GLP-1, LDL-C, HDL-C, triglyceride, RLP-C, and free fatty acid after meal tolerance test, for each measurement point will be evaluated with descriptive statistics Amounts and changing value of HbA1c, blood glucose, glycosylated albumin and 1.5-AG for each measurement point will be evaluated with descriptive statistics Safety endpoints:The incident rate and the situation of side effects and adverse events during observation and treating periods. Laboratory evidence is the use of descriptive statistics. | — |
Countries
Japan
Contacts
Public ContactErika Yamagishi
NPO Advanced Clinical Research Organization NPO Advanced Clinical Research Organization
Outcome results
None listed