NCT00940472已完成2 期
Randomized, Double-Blind, Efficacy and Safety, Controlled Study, Between DMMET-01 and Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetics Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)
研究概览
简要总结
The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages eligible for study: 40 to 60 years
- •With type 2 diabetes evolution < 5 years without pharmacological treatment 1 month prior to the screening
- •Fasting glucose = 130-200 mg/dL
- •HbA1c of 7% to 9%
- •Blood pressure < 140/80 mmHg
- •Ability to communicate and meet the requirements of the study
- •Signed Written Informed Consent before to conducting any study
- •Body mass index (BMI) of 25 kg/m2 to 35 Kg/m2
排除标准
- •Suspected or confirmed pregnancy
- •Inability to secure the non-pregnant during the study duration
- •Hypersensitivity to any biguanides
- •Use of an investigational drug within 30 days prior to the screening
- •Liver failure, heart failure, kidney failure or thyroid disease
- •Periods of acute or chronic diarrhea or vomiting
- •Chronic hepatic disease
- •Total Cholesterol >300 mg/dL
- •Triglycerides >400 mg/dL
研究组 & 干预措施
Experimental Drug
Experimental
DMMET-01 + Diet
干预措施: DMMET-01 (Drug)
Metformin
Active Comparator
Metformin + Diet
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)
时间窗: 3 months
次要结局
- Lipid Profile (Total cholesterol, HDL, LDL, triglycerides)(3 months)
- Adverse Events(4 months)
研究者
研究点 (1)
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