type2 diabetes
Conditions
Interventions
0th week: Perform examination under fasting conditions at the clinic. Perform examination again after the patients, who have signed a consent form, take an agent of a-GI or Glinide, and take a meal to
Sponsors
Advanced Clinical Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients poorly controlled with the monotherapy of a-GI or glinide in addition to diet and exercise regimen, and regarded as appropriate to be treated with Glubes combination tablets. 2) Patients who have 6.5% HbA1c or more. 3) Age 20<= 4) Outpatient 5) Patients who voluntarily signed to the consent form with the 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:HbA1c(the JDS), blood glucose, glycated albumin, insulin, 1.5-AG, C-peptide, free fatty acids, triglycerides, apoB48, and apoC-3. Calculate HOMA-IR and HOMA-B in order to evaluate insulin resistance and function of pancreatic beta cell at each evaluation point. Primary endpoints:HbA1c(the JDS) at the final evaluation point of each patient. Compare the items of efficacy endpoints and the descriptive statistical number of the changing rate at each evaluation points, to the rate at 0week with t-test. Calculate the 6.5% achievement ratio of HbA1c at each evaluation points. Study the efficacy of taking a-GI or each glinide drugs which had been used before this study. Safety endpoints:Evaluate the frequency and the occurrence of adverse events during this study. Calculate the number of events and cases on the treatments of every 4 weeks, and calculate the total number of events and cases. Analyze the adverse events against the drug by its grade, organ, and causal relationship. Measure the descriptive statistics of observation period(0week) and treatment period(16th week) as laboratory evidences, and find the ratio of appearance of unusual change on each test values. Measure the transitions of values of weights and blood pressures, on every 4 weeks of treatment periods. | — |
Countries
Japan
Contacts
Public ContactErika Yamagishi
NPO Advanced Clinical Research Organization NPO Advanced Clinical Research Organization
Outcome results
None listed