A 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adults Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,736
- 试验地点
- 47
- 主要终点
- Adjusted Mean Change From Baseline in HbA1c
研究概览
简要总结
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR 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
- 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
- 否
入选标准
- •Men and women, aged ≥18 years old at time of enrollment
- •Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone
- •Women must have a negative serum or urine test within 24 hours prior to start of investigational product
排除标准
- •History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma
- •Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with >10% weight loss during last 3 months
- •Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40 mg/dL (124 μmol/L for female subjects)
研究组 & 干预措施
Arm 1: Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks
干预措施: Metformin XR (Drug)
Arm 1: Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks
干预措施: Placebo matching with Metformin XR (Drug)
Arm 2: Metformin IR and Placebo matching with Metformin IR
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks
干预措施: Metformin IR (Drug)
Arm 2: Metformin IR and Placebo matching with Metformin IR
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks
干预措施: Placebo matching with Metformin IR (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in HbA1c
时间窗: Baseline and Week 24
Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.
Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation
时间窗: Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.
次要结局
- Mean Change in Fasting Plasma Glucose (FPG)(Baseline and Week 24)
- Percent of Participants With HbA1c < 7%(Week 24)
- Mean Change in Mean Daily Glucose (MDG)(Baseline and Week 24)