Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 5
- 主要终点
- Compare changes in HbA1
研究概览
简要总结
Phase IIIb, randomized, multicenter, double-blind, prospective study to evaluate the efficacy and safety of a daily fixed-dose combination of glimepiride / vildagliptin / metformin in patients with type 2 diabetes with a history of dual treatment failure and combined or individual oral antidiabetics with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4 or Biguanide / iDPP4. To evaluate the changes in the percentage of HbA1c at 3 and 6 months with regard to their baseline measurement.
详细描述
To achieve glycemic control goals, a combination of medications with complementary mechanisms of action, with fasting and postprandial effects, may be required to achieve and maintain clinically acceptable glycemic control in some patients. A fixed combination of two or more therapeutic agents with complementary mechanisms of action makes it possible to optimize compliance and adherence to treatment among patients with T2D because it is administered once a day with the same efficacy of the separate components, but with fewer gastrointestinal effects. This is reflected in a reduction in HA1c and a lower evolution to long-term complications of T2D. Phase IIIb, randomized, multicenter, double-blind, prospective study to evaluate the efficacy and safety of a daily fixed-dose combination of glimepiride / vildagliptin / metformin in patients with type 2 diabetes with a history of dual treatment failure and combined or individual oral antidiabetics with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4 or Biguanide / iDPP4.
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
- •Male or Female.
- •Age >18 years old at the beginning of the study.
- •Diagnosis of type 2 diabetes prior to the start of the study.
- •Therapeutic failure to a dual treatment with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4, Biguanide / iDPP
- •HbA1c ≥ 7.5% and ≤ 11% during screening tests.
- •Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal) or naturally or surgically sterile in menopause.
- •Subject agree to participate in the study and give informed consent in writing.
排除标准
- •The drug is contraindicated for medical reasons.
- •History of Type 1 Diabetes Mellitus.
- •History of metabolic complications such as ketoacidosis or nonketotic hyperosmolar state.
- •History of gastric bariatric surgery or gastric band in the last year.
- •History of drug or alcohol abuse in the past year.
- •Body Mass Index <20 kg/m2 and >40 kg/m
- •Acute or severe renal dysfunction (glomerular filtration <30 ml / min / 1.72 m2).
- •History of chronic liver disease or ALT and / or AST ≥3 times the normal upper limit and / or Total Bilirubin> 2.5 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.
- •Pregnant and / or lactating women.
- •The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
- •At medical criteria, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness, with scheduled surgical or hospital procedures.
- •Be a patient with a working relationship with the main researcher or the research center or deprived of liberty.
研究组 & 干预措施
Group A1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg).
Tablets, orally, once a day. Initial dose for the first 45 days of intervention.
干预措施: A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg) (Drug)
Group B1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg)
Tablets, orally, once a day. Initial dose for the first 45 days of intervention.
干预措施: B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg) (Drug)
Group A2: Glimepiride (2mg) / Vildagliptin (50mg) / Metformin (1000mg)
Tablets, orally, once a day. Dose escalation if the patients meets established criteria.
干预措施: (A2) Glimepiride/Vildagliptin/Metformin (Drug)
Group B2: Glimepiride (4mg) / Vildagliptin (50mg) / Metformin (1000mg)
Tablets, orally, once a day. Dose escalation if the patients meets established criteria.
干预措施: (B2) Glimepiride/Vildagliptin/Metformin (Drug)
结局指标
主要结局
Compare changes in HbA1
时间窗: baseline, 3 and 6 months of treatment
Mean change in HbA1c
Proportion of patients who change their HbA1c concentration
时间窗: baseline, 3 and 6 months of treatment
Proportion of patients who change their HbA1c by at least 1 percent
Mean difference change between groups in HbA1c concentration
时间窗: baseline, 3 and 6 months of treatment
Difference greater than 0.3 between group A and B HbA1c concentration
次要结局
- Incidence of adverse events and reactions(baseline, 3 and 6 months of treatment)
- Mean glucose change(baseline, 3 and 6 months of treatment)