Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
Phase III study to evaluate the efficacy and safety of the treatment. Two-arm, prospective, longitudinal, double-blind, multicenter randomized clinical trial.
详细描述
Study to evaluate the efficacy and safety of treatment at 6 and 12 months with metformin glycinate at a dose of 2100 mg / day compared to metformin hydrochloride at a dose of 1700 mg / day on the progression of type 2 diabetes. To assess the change in HbA1c from baseline to 6 and 12 months of treatment (primary endpoint) in both groups. As secondary objectives, changes in fasting glucose levels from baseline, changes in results of the oral glucose tolerance test 2h from baseline, changes in HOMA-IR from baseline, changes in insulin levels, leptin, adipokines and proinflammatory cytokines, MCP-1, nitric oxide and PCr from baseline, changes in BMI from baseline and changes in lipid profile from baseline will be evaluated. A blinded interim analysis will be performed at 6 months of patient follow-up and a final analysis. Demographic data will be analyzed with mean, standard deviation, minimum and maximum. Efficacy analyzes will be carried out in the treated population (all treated patients, ATP), made up of all randomized patients who received at least one dose of the study treatment and who have a baseline measurement and at least one subsequent measurement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects ≥18 years old.
- •Type 2 diabetes according to ADA diagnostic criteria.
- •Naive to treatment or who have previously been under oral hypoglycemic treatment (whatever it may be), as long as it has been suspended for a period of ≥6 weeks prior to the start of the study. - HbA1c ≥7.5% and <10.0%.
- •In the case of women of childbearing age and with an active sexual life, the use of birth control methods is required; any of the following are accepted: barrier (male or female condom), non-hormonal intrauterine device, or bilateral tubal obstruction.
- •That you agree to participate in the study and give written informed consent.
排除标准
- •Patients with known current abuse or dependence (last 2 months) to substances such as alcohol (weekly consumption> 21 units of alcohol in men or> 14 units of alcohol in women) or recreational drugs.
- •Body Mass Index <20 kg / m2 and> 35 kg / m
- •Glomerular filtration estimated with the MDRD (Modification of Diet in Renal Disease) procedure through serum creatinine <60 ml / min / 1.72 m
- •History of chronic liver disease or ALT (alanine aminotransferase) and / or AST (aspartate aminotransferase) ≥ 2 times the upper limit of normal, or GGT (Gamma glutamyl transpeptidase) ≥3 times the upper limit of normal.
- •Chronic lung disease, causing dyspnea equivalent to a functional class ≥3 (NYHA) or requiring oxygen supplementation.
- •Use of drugs that interact with biguanides.
- •Other chronic diseases that limit survival or are associated with chronic inflammation such as: cancer, leukemia, lymphoma, lupus erythematosus, asthma, rheumatoid arthritis, or HIV (human immunodeficiency virus) infection.
- •Pregnancy or positive pregnancy test, as well as women who are breastfeeding.
研究组 & 干预措施
Group A: Metformin glycinate 1050 mg
Metformin glycinate 1050 mg Orally twice a day.
干预措施: Metformin glycinate (Drug)
Group B: Metformin hydrochloride 850 mg
Metformin hydrochloride 850mg Orally twice a day.
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Baseline, 6 and 12 months
Assess change in HbA1c
次要结局
- Changes in fasting glucose(Baseline, 6 and 12 months)
- Changes in insulin levels(Baseline, 6 and 12 months)
- Changes in leptin levels(Baseline, 6 and 12 months)
- Changes in adipokine levels(Baseline, 6 and 12 months)
- Changes in nitric oxide levels(Baseline, 6 and 12 months)
- Change in the 2-hour oral glucose tolerance curve(Baseline, 6 and 12 months)
- Changes to HOMA-IR (Homeostatic model assessment and Insulin resistance(Baseline, 6 and 12 months)
- Changes in body mass index(Baseline, 6 and 12 months)
- Incidence of adverse events(Baseline, 6 and 12 months)
- Changes in proinflammatory cytokine(Baseline, 6 and 12 months)
- Changes in levels of MCP-1 (monocyte chemoattractant protein 1)(Baseline, 6 and 12 months)
- Changes in C-reactive protein levels(Baseline, 6 and 12 months)