SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With Type 2 Diabetes Mellitus (T2D) Inadequately Controlled With Metformin Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 689
- 试验地点
- 1
- 主要终点
- Absolute Change From Baseline in HbA1c at Week 24 (DAO)
研究概览
简要总结
SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy
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
- 18 Years 至 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus
- •Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening.
- •T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated dose), but not more than the maximum dose specified in the label
- •HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central laboratory)
- •FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)
- •Able and willing to provide written informed consent and to comply with the study protocol
排除标准
- •Women who are pregnant, intending to become pregnant during the study period, lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
- •Diagnosis or history of:
- •Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
- •Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
- •Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year.
- •History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
- •Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening
研究组 & 干预措施
Saxagliptin
The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
干预措施: Saxagliptin (Drug)
Acarbose
Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
干预措施: Acarbose (Drug)
结局指标
主要结局
Absolute Change From Baseline in HbA1c at Week 24 (DAO)
时间窗: From baseline to 24 week
The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.
次要结局
- Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%(24 weeks)
- Change From Baseline in Body Weight(From baseline to 24 week)
- Change From Baseline in 2H Postprandial Glucose (2HPPG)(From baseline to 24 week)
- Change From Baseline in HOMA-β(From baseline to 24 week)
- Proportion (%) of Patients With Any GI Adverse Events(24 weeks)
- Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events(Whole study duration)
- Change From Baseline in Fasting Plasma Glucose (FPG)(From baseline to 24 week)