None listed
Conditions
Interventions
Drug : For more than 8 weeks with insulin (once a day), pre-mixed insulin (once or twice a day), basal bolus injection (once a day basal, 1-2 times a bolus) and metformin 2 Randomized placebo or adjun
Sponsors
Kyung Hee University Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Screening (V1) At the age of 19 years or older, type 2 diabetic patients ? Body mass index ? 45 kg / m2 ? patients whose HbA1c was 7.0% or more and 10.0% or less at the time of screening (V1) ? Patients who received stable insulin for the previous 8 weeks on the basis of screening (V1) (without any change of insulin type, the total daily dose should be at least 10 U / day and maximum 1 U / kg / Defined as the case where the total average daily dose was adjusted to within ± 10% for 8 weeks). ? When taking metformin, patients who were taken without a change of dose for 8 weeks before screening (V1) ? Those who have voluntarily agreed in writing to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: It is the exclusion criterion that it corresponds to taboo administration of "use precautions" in the permission of guardlet tablet, metformin tablet, and insulin. ?patients with renal disease or renal insufficiency (GFR <30 mL / min / m2), which can be caused by conditions such as cardiovascular collapse, acute myocardial infarction and sepsis ? Patients with congestive heart failure who need medication ? Patients with a history of hypersensitivity to the main ingredient (anagliptin) or other ingredients (including acetaminophen) ? Patients using DPP-4 inhibitor and other diabetes remedy (SGLT2 inhibitor, thiazolidinedione, GLP-1 receptor agonist, sulphonylating agent, glinidie, alpha glucosidase, etc.) within 8 weeks based on screening point (V1) ? diabetic ketoacidosis, diabetic coma or total coma, type 1 diabetes patients ? Patients with severe infection, pre- and post-operative, severe trauma ? hepatic dysfunction (AST or ALT more than three times the upper limit of normal), menopausal color, severe pulmonary dysfunction and other conditions that are likely to entail hypoxemia, excessive alcohol consumption, gastrointestinal disorders such as dehydration, diarrhea and vomiting patient ? Women who are pregnant or who may be pregnant, nursing mothers ? Patient with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency ? patients with postmenopausal or severe pulmonary dysfunction ? Patients with hypersensitivity to insulin or insulin additive ? Other patients who were deemed inappropriate by the examiner as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare HbA1C changes | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects subject to HbA1c <7.0% after 24 weeks of treatment;Percentage of subjects subject to HbA1c <6.5% after 24 weeks of treatment;Fasting blood glucose and fasting blood glucose change relative to baseline after 24 weeks;4 points after 24 weeks SMBG(Self Monitoring Blood Glucose) and 4 points compared to baseline SMBG(Self Monitoring Blood Glucose) change;Daily average insulin dose change relative to baseline after 24 weeks of treatment;Changes in total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol and baseline values after 24 weeks of treatment;Changes in HbA1c after 12 weeks compared to baseline (HbA1c-basal HbA1c after 12 weeks);Fasting blood glucose and fasting blood glucose changes compared to baseline after 12 weeks;4 points after 12 weeks SMBG and 4 points compared to baseline SMBG change;Daily average insulin dose change relative to baseline after 12 weeks of treatment;Changes in urine albumin / Cr ratio versus baseline in urine albumin / Cr ratio after 24 weeks | — |
Countries
Korea, Republic of
Contacts
Public Contactjunghwa lee
Kyung Hee University Hospital at Gangdong
Outcome results
None listed