NCT00437554已完成3 期
A 16-Week Controlled, Double Blind, Double Dummy, Randomized, Two Arm Parallel-Group Study to Compare the Efficacy and Safety of Amaryl M 1/250 mg b.i.d vs. Amaryl M SR 2/500 mg od. in Patients With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Efficacy : Change in HbA1c between baseline and endpoint
研究概览
简要总结
Primary:
To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on HbA1c in patients with type 2 Diabetes Mellitus (DM)
Secondary: To compare the following parameters in two treatment arm
- Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h)
- Response rates in terms of HbA1c, FPG
- Patient compliance
Safety:
- episodes of hypoglycemia
- adverse events
- laboratory values including hematology blood chemistry and urinalysis
- vital sign and physical examination
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
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 DM diagnosed for at least 3 months but no longer than 10 years before screening;
- •- BMI ≤ 40 kg/m²;
- •A negative pregnancy test for all females of childbearing potential
排除标准
- •A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening;
- •Current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening;
- •Concomitant treatment prohibited during the study period;
- •Any oral anti-diabetic drugs other than study medication
- •Any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
- •Intermittent use of systemic corticosteroids or large dose of inhaled steroids
- •Subjects with clinically significant renal (serum creatinine level >1.5 mg/dL in male and >1.4 mg/dL in female) or hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2x upper limit of normal (ULN));
- •Subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.)
- •Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
- •Pregnant or lactating females;
- •History of drug or alcohol abuse;
- •Subjects with known hypersensitivity to glimepirides, or metformin; Night-shift workers;
- •Treatment with any investigational product in the last 3 months before study entry;
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Efficacy : Change in HbA1c between baseline and endpoint
次要结局
- Efficacy : Change in HbA1c measured at baseline, week 8 and week 16. Change in FPG and PP2h measured at baseline, week 8 and week 16. Response rates in terms of HbA1c, FPG.Patient compliance
- Safety: episodes of hypoglycemia, adverse events, laboratory values including hematology, blood chemistry and urinalysis, vital sign and physical examination, Frequency with hypoglycemic episode
研究者
研究点 (2)
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