Evaluation of the efficacy and safety of addition of Gardret tablets to patients with type 2 diabetes whose insulin and metformin combination therapy failed to control blood glucose
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004092
- Lead Sponsor
- Kyung Hee University Hosipital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 96
? 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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare HbA1C changes
- Secondary Outcome Measures
Name Time Method