Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 4
- 主要终点
- Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2 diabetes patients, in a 12 months follow up.
详细描述
Metformin glycinate salt is a new drug , which has better pharmacokinetic characteristics (better bioavailability and absorption) making a proper antihyperglycemic power without increasing the frequency of adverse effects. The drug has been tested in preclinical test with animals, in healthy subjects and in patients with type 2 diabetes; which showed that it has adequate antihyperglycemic effect. Now, its important to compare metformin glycinate and metformin hydrochloride for evaluate the relative antihyperglicemic power. In addition, a study with a larger number of patients improve the statistical power of the test to investigate the effects of these drugs on possible weight loss and lipid profile improve. Additionally, it will also explore the relative power of the two medications tested to modify inflammatory response mediators and oxidative stress have been associated with the incidence of cardiovascular disease in diabetes. This project was designed with the intent to answer the next question: What are the efficacy and safety of metformin glycinate dose of 2101.2 mg/day (equivalent to 1700 mg/day metformin hydrochloride), compared with metformin hydrochloride in doses of 1700 mg/day for 12 months of treatment in patients with Type 2 diabetes.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes according ADA
- •Less than a year of evolution since diagnosis
- •Without antihyperglycemic pharmacological treatment
- •HbA1c between 6.5% and 9.5%
- •Stable weight during the last 6 months
- •Body Mass Index ≥ 25 kg/m2 and <35kg/m
- •Blood pressure ≤ 130/80 mmHg
- •Childbearing women under contraceptive treatment
- •Signed Informed Consent Form
- •Age from 18 to 70 years old
排除标准
- •Non-fulfilment treatment in the screening period
- •Smoking up to 1 year before the initial examination
- •Drugs or alcohol abuse
- •Creatinine depuration estimated with MDRD formula using serum creatinine < 90 ml/min/1.72m2
- •History of chronic liver disease, ALT or AST ≥ 2 times from the normal superior limit, or GGT ≥ 3 times from the normal superior limit.
- •Chronic lung disease, that causes dyspnea equivalent to a functional class ≥3 (NYHA)or that requires oxygen supplementation.
- •History or symptoms of coronary artery disease (CAD) or cerebrovascular disease (CVD).
- •Drug treatment that interact with biguanides.
- •Another chronic diseases that restricts survival or associated with chronic inflammation like: cancer, leukemia, lymphoma, erythematosus lupus, asthma, rheumatoid arthritis or infection for HIV.
- •Pregnancy or positive pregnancy test in women under 50 years old or breastfeeding.
研究组 & 干预措施
Metformin Hydrochloride
Metformin Hydrochloride is the biguanide most used, for this study the dose administrated will be 850 mg OD for a month, and 850 mg BID for 11 months.
干预措施: Metformin hydrochloride (Drug)
Metformin glycinate
Metformin glycinate is a new biguanide, for this study the dose administrated will be 1050.6 mg OD for a month, and 1050.6 mg BID for 11 moths.
干预措施: Metformin glycinate (Drug)
结局指标
主要结局
Glycosylated hemoglobin (HbA1c)
时间窗: 12 months
HbA1c: Measured by electrophoresis of lacked total blood using Paragon system and Appraise reader 44800 (Beckman Instruments de Mexico). Fasting Glucose: in serum using glucose oxidase technique with BM/Hitachi 704/911 automated analyzer
次要结局
- Number of Adverse Events as a Measure of Safety and Tolerability(12 months)
- Malonylaldehyde(12 months)
- High-density lipoprotein (HDL)(12 months)
- Tumor necrosis factor-alpha (TNF-α)(12 months)
- Total cholesterol(12 months)
- Low-density lipoprotein (LDL)(12 months)
- Interleukin-1 beta (IL-1β)(12 months)
- Fasting glucose(12 months)
- Triglycerides(12 months)
- Adiponectin(12 months)
- Resistin(12 months)
- Dismutase superoxide(12 months)