KCT0002852招募中未知
Randomization for efficacy and safety Phase 4 clinical trials of conversion of basal insulin/metformin/lobeglitazone or basal insulin/metformin/linagliptin in insufficient glycemic control type 2 diabetic patients with combination therapy with basal insulin/metformin or basal insulin/metformin/sulfonyl urea or basal insulin/metformin/DPP-4 inhibitor
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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