NCT01787396已完成3 期
A Multicenter, Randomized, Active-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d Compared With Either Monotherapy in Treatment naïve Patients With Type 2 Diabetes
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 433 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus
- •Adults over 20 of age
- •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
- •Patients with hemoglobin A1c (HbA1c) between 7.5%~11% at Visit 2(randomization)
排除标准
- •Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
- •Patients with gestational diabetes, or secondary diabetes
- •Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
- •Patients with dysfunctional thyroid gland (with abnormal level of TSH)
- •Patients with active bladder cancer.
- •Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
- •Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
- •Patients with pituitary insufficiency or adrenal dysfunction.
- •Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
- •Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)
- •Female patients who is gravida or in lactiferous phase or confirmed pregnancy by serum or urine.
- •Patients with body mass index (BMI) below 20 kg/m2 or exceeding 40 kg/m2
- •Male patients with Serum Creatinine level over 1.5mg/dl, Female patients with serum creatinine over 1.4mg/dl.
- •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
- •Patients who were taking or needed to take any drugs that may affect the control of blood glucose significantly (ex. glucocorticoids)
- •Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
- •Patients taking CYP3A4 inducers.(ex, Rifampicin(Rifampin), Dexametha-sone, Phenytoin, Carbamazepine, Rifabutin, Phenobarbital)
- •Patients taking Furocemide, Nifedipine, Cimetidine
- •Patients who were treated with Anti-obesity drugs in the last 12 weeks prior to Visit 1(screening)
- •Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or in the last 6 months prior to Visit
- •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
- •Patients with history of addiction to alcohol or drugs within 1year prior to Visit 1(screening).
- •Patients with history of Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
- •Patients with history of hypersensitivity to gemiglpitin or Dipeptidyl-peptidase4(DPP4) inhibitors.
- •Patients with history of hypersensitivity to metformin or biguanides.
- •Patients with history of hypersensitivity to Pioglitazone HCl or Thiazolidinediones
- •Patients who participated in other clinical trial within 3 months prior to Visit1(screening).
- •Patients with other reasons who the investigator decided not to be eligible for the study
研究组 & 干预措施
Arm1
Experimental
Gemigliptin 50mg + Metformin Once daily with dinner
干预措施: Gemigliptin 50mg (Drug)
Arm1
Experimental
Gemigliptin 50mg + Metformin Once daily with dinner
干预措施: Metformin (Drug)
Arm 2
Experimental
Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner
干预措施: Gemigliptin 50mg (Drug)
Arm 2
Experimental
Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner
干预措施: Placebo(Metformin) (Drug)
Arm3
Experimental
Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner
干预措施: Metformin (Drug)
Arm3
Experimental
Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner
干预措施: Placebo(Gemigliptin) (Drug)
结局指标
主要结局
HbA1c
时间窗: 24weeks
Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)
次要结局
未报告次要终点
研究者
研究点 (1)
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