None listed
Conditions
Interventions
Drug : Experimental group: Basal insulin+Metformin+lobeglitazone 0.5mg(s.i.d., oral administration, 24 weeks)
Control group: Basal insulin+Metformin+linagliptin 5mg(s.i.d., oral administration, 24 wee
Sponsors
Inje University Busan Paik Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible for inclusion in this trial: 1. Patients with type 2 diabetes mellitus. 2. Patients aged 19 to 80 years. 3. Patients with Glycosylated Hemoglobin, Type A1C = 7.0% after 2-drug therapy (basal insulin and metformin) or 3-drug therapy (basal insulin, metform in, and Dipeptidyl peptidase-4 inhibitor or Sodium Glucose Co-Transporter-2 inhibitor) for 3 months or more. *Patients administered with basal insulin for 3 months or more and volume of the basal insulin are controlled within ±1 0% during recent 1 month. *Patients administered with metformin 1,000 mg/day or more (fixed dose) for 3 months or more. 4. Patients who can understand and follow the instruction. 5. Patients who agreed to participate in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Patients to whom any of the following criteria apply will be excluded from this study: 1. Body Mass Index (BMI) of <20 kg/m2 or >45 kg/m2. 2. Patients with serious heart failure or any history of heart failure (New York Heart Association class III&IV). 3. Patients with cardiac infarction, acute cardiovascular disease or cerebrovascular disease past 6 months from the screening examination. 4. Patients with uncontrollable hypertension (In spite of the sufficient administration of more than 3 medicines including diuretics, still its blood pressure of more than 160/100 mmHg). 5. Patients with gastrointestinal disorder including diarrhoea, vomiting or etc. 6. Patients who administered weight loss medicine or hypoglycemic drug excepting metformin, basal insulin, sulfonyl urea, Dipeptidyl peptidase-4 inhibitor and Sodium Glucose Co-Transporter-2 inhibitor within 3 months since the screening examination. 7. Patients with Allergy or hypersensitivity reaction to the investigational product or any of the agents used in the study. 8. Patients with diabetic ketoacidosis, diabetic coma, pre-coma or diabetes mellitus, type 1. 9. Patients with genetic disorders including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 10. Patients who administered systemic steroids past 6 months from the screening examination. 11. Patients who underwent acute metabolic complications past 6 months from the screening examination (Ketoacidosis or condition of hyper osmotic pressure). 12. Patients who meet any of the following - Hemoglobin = 12 g/dL(male), 10 g/dL(female) - Estimated Glomerular Filtration Rate < 45 mL/min/1.73m2 - Alanine AminoTransferase > 2.5 X upper limit of normal - Aspartate aminotransferase > 2.5 X upper limit of normal - TriGlyceride>500 mg/dL - Low-density lipoprotein cholesterol=175 mg/dL 13. History of laser therapy for proliferative Diabetic Retinopathy. 14. Patients with excessive alcohol intake Male: over 21 units every week for recent 1 year. Female: over 14 units every week for recent 1 year. *Alcohol (units) formula: [intake (ml) x alcohol content x 0.8 (alcohol gravity)]/1000 For example) Soju (standards: 20 percent alcohol content, 360ml) 1 bottle is approximately 5.7 units, Beer (standards: 4.5 percent alcohol content, 500ml) 1 bottle is approximately 1.8 units 15. Patients diagnosed drug abuse based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria. 16. Patients who have a malignant tumor (excepting patients who have passed 5 years after the complete response). 17. Patients who are not possible to use insulin. 18. Patients who have history of bladder cancer. 19. Patients who have history of major surgery past 3 years from the screening examination. 20. Patients with severe infectious disease or major trauma before or after surgery. 21. Pregnancy or lactating women. 22. Patients unconsented to use medically accepted contraception within the study period and 4 weeks after the study completed. *Medically accepted contraception methods: condom, oral contraception at least 12 weeks, contraceptive injection, contraceptive vaginal ring, intrauterine Device or etc. 23. Medically judged by the investigator to be inadequate in accordance with the standard values of the study and other clinical criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Glycosylated Hemoglobin, Type A1C level | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Glycosylated Hemoglobin, Type A1C level;Decreased ratio in insulin demand amount;Changes in fasting blood sugar level;Patients ratio that reached Glycosylated Hemoglobin, Type A1C < 7.0%;Patients ratio that reached Glycosylated Hemoglobin, Type A1C < 6.5% without hypoglycemia;Changes in Low Density Lipoprotein-cholesterol, High Density Lipoprotein-cholesterol, and Triglyceride level from the baseline;Changes in Alanine AminoTransferase/Aspartate Aminotransferase level from the baseline;Changes in Homeostasis model assessment for insulin resistance and Homeostasis Model Assessment of ß-Cell level from the baseline;Changes in Adiponectin level from the baseline;Changes in high sensivity-C reactive protein level from the baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactSoon Hee Lee
Inje University Busan Paik Hospital
Outcome results
None listed