A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean Change in HbA1c From Baseline to Week 16
研究概览
简要总结
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes
详细描述
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
- •Previously diagnosed as having type 2 diabetes
- •HbA1c ≥7.0% and ≤10.5%
- •Body weight ≥ 30 kg
- •Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
- •Women must have a negative serum or urine pregnancy test
- •Women must not be breastfeeding
排除标准
- •Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
- •Fasting plasma glucose (FPG) > 255 mg/dL
- •Diabetic ketoacidosis (DKA) within 6 months of study entry
- •Abnormal renal function
- •Active liver disease
- •An abnormal Thyroid Stimulating Hormone (TSH)
- •Creatinine kinase (CK) ≥ 3X ULN
研究组 & 干预措施
Arm 2: Placebo +Metformin XR/IR
Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
干预措施: Metformin XR (Drug)
Arm 1: Saxagliptin +Metformin XR/IR
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg
干预措施: Metformin IR (Drug)
Arm 1: Saxagliptin +Metformin XR/IR
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg
干预措施: Metformin XR (Drug)
Arm 1: Saxagliptin +Metformin XR/IR
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg
干预措施: Saxagliptin (Drug)
Arm 2: Placebo +Metformin XR/IR
Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
干预措施: Placebo matching with Saxagliptin (Drug)
Arm 2: Placebo +Metformin XR/IR
Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
干预措施: Metformin IR (Drug)
结局指标
主要结局
Mean Change in HbA1c From Baseline to Week 16
时间窗: 16 week short term treatment period
次要结局
未报告次要终点