TCTR20191213002已完成3 期
Efficacy and safety of initial combination therapy with gemigliptin and metformin compared with monotherapy with either drug in patients with type 2 diabetes: A double-blind randomized controlled trial (INICOM study)
G Life Sciences0 个研究点目标入组 433 人开始时间: 2019年12月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 433
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 100 Years（—）
- 性别
- All
入选标准
- •1. Patients with type 2 diabetes mellitus
- •2. Adults over 20 of age
- •3. Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).
- •Patients with no previous antidiabetic drugs
- •4. Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)
排除标准
- •1. Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
- •2. Patients with gestational diabetes, or secondary diabetes
- •3. Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
- •4. Patients with dysfunctional thyroid gland (with abnormal level of TSH)
- •5. Patients with active bladder cancer.
- •6. Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
- •7. Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
- •8. Patients with pituitary insufficiency or adrenal dysfunction.
- •9. Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
- •10. Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)
- •11. Female patients who is gravida or in lactiferous phase or confirmed pregnancy by serum or urine.
- •12. Patients with body mass index (BMI) below 20 kg/m2 or exceeding 40 kg/m2
- •13. .Male patients with Serum Creatinine level over 1.5mg/dl, Female patients with serum creatinine over 1.4mg/dl.
- •14. Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), exceeding 2.5 times or bilirubin exceeding 1.5 times of the upper limit of the normal range
- •15. Patients who were taking or needed to take any drugs that may affect the control of blood glucose significantly (ex. glucocorticoids)
- •16. Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
- •17. Patients taking CYP3A4 inducers.(ex, Rifampicin(Rifampin), Dexametha-sone, Phenytoin, Carbamazepine, Rifabutin, Phenobarbital)
- •18. Patients taking Furocemide, Nifedipine, Cimetidine
- •19. Patients who were treated with Anti-obesity drugs in the last 12 weeks prior to Visit 1(screening)
- •20. Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or in the last 6 months prior to Visit 1.
- •21. Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to Visit1(screening), or patients with arrhythmia requiring treatment
- •22. Patients with history of addiction to alcohol or drugs within 1year prior to Visit 1(screening).
- •23. Patients with history of Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
- •24. Patients with history of hypersensitivity to gemiglpitin or Dipeptidyl-peptidase4(DPP4) inhibitors.
- •25. Patients with history of hypersensitivity to metformin or biguanides.
- •26. Patients with history of hypersensitivity to Pioglitazone HCl or Thiazolidinediones
- •27. Patients who participated in other clinical trial within 3 months prior to Visit1(screening).
- •28. Patients with other reasons who the investigator decided not to be eligible for the study
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