Efficacy and Safety of Saxagliptin and Glimepiride in Chinese Patients With Type 2 Diabetes Controlled Inadequately With Metformin Monotherapy (SPECIFY Study) : a 48-week, Multi-center, Randomized, Open-label Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0%
研究概览
简要总结
This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
详细描述
This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
Screening will be made to select eligible participants before intervention. The trial will include 1-week run-in period of stable doses of metformin (1500mg) and 48-week treatment period. After the run-in period, patients were randomly assigned to one of two groups for antihyperglycaemic therapies for a total of 48-weeks: saxagliptin and glimepiride. The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the study. Glimepiride will be initially treated with 1 mg every morning, and further titrated up at 4-week intervals until to reach the target fasting blood glucose (FPG).As to Glimepiride groups, if the fasting blood glucose dose not achieved the target after the maximal doses, maintain the maximal doses(6mg per day) until the completion of the study.Meanwhile, participants in both groups should take metformin 1500mg per day throughout the whole 48 weeks. At the end of the study, data will be collected and analyzed.
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
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study subjects should fulfill the following criteria:
- •Provision of informed consent prior to any study specific procedures
- •Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
- •Male or female age ≧ 25 years and ≦75 years old
- •HbA1c ≧7.0 and ≦9.5%
- •BMI ≧ 20 and ≦ 30 kg/m2
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •Known or suspected allergy to trial products or related products.
- •Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dL (≥ 132.6 μmol/l).
- •Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
- •Hepatic insufficiency, acute alcohol intoxication, alcoholism.
- •Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class Ⅲ and Ⅳ).
- •Proliferative retinopathy or muscular oedema requiring acute treatment.
- •Lactation.
- •Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
- •Treatment with systemic corticosteroids within the past two months prior to screening.
- •Tested positive for glutamic acid decarboxylase antibody.
- •Receipt of any investigational drug within 1 month prior to this trial.
研究组 & 干预措施
Saxagliptin
The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.
干预措施: Saxagliptin (Drug)
Saxagliptin
The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.
干预措施: Glimepiride (Drug)
Glimepiride
Glimepiride will be initially treated with 1 mg every morning to a dose of 6 mg/day.a.m. Every 4-week the subjects will be evaluated whether reach the target fasting plasma glucose (assayed by finger-stick ≦6.1 mmol/l ). If the fasting blood glucose not achieved the target at the maximum dose, maintain the maximum dose(6mg/d) until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.
干预措施: Saxagliptin (Drug)
Glimepiride
Glimepiride will be initially treated with 1 mg every morning to a dose of 6 mg/day.a.m. Every 4-week the subjects will be evaluated whether reach the target fasting plasma glucose (assayed by finger-stick ≦6.1 mmol/l ). If the fasting blood glucose not achieved the target at the maximum dose, maintain the maximum dose(6mg/d) until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.
干预措施: Glimepiride (Drug)
结局指标
主要结局
Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0%
时间窗: Change from Baseline after 48 weeks treatment
Compare the proportion of subjects after 48-week treatment achieving HbA1c\<7.0%, with no hypoglycemia and no body weight gain (defined as glucose \< 3.9 mmol/L with or without symptoms and weight gain \< 3.0%).
次要结局
- The change in blood glucose fluctuations of subjects.(Change from Baseline after 48 weeks treatment)
- The improvement in beta-cell function of subjects(Change from Baseline after 48 weeks treatment)
- The change in body composition of subjects.(Change from Baseline after 48 weeks treatment)
- Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests(Change from Baseline after 48 weeks treatment)
研究者
Dalong Zhu
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School