A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled Study, to Evaluate the Efficacy and Safety of Janagliflozin (25 mg and 50 mg) as Monotherapy in Chinese Patients Diagnosed With T2DM
试验速览
- 阶段
- 3 期
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to Week 24
研究概览
简要总结
The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics.
详细描述
A multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 Weeks Extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg. During the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally once daily.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have a diagnosis of T2DM (meet the diagnostic criteria for diabetes issued by the World Health Organization in 1999)
- •Patients must have a hemoglobin A1c (HbA1c) level ≥7.5% and ≤11% at screening, and ≥7.0% and ≤10.5% at baseline.
- •Drug -naïve (never received anti-diabetic medication or did not receive anti-diabetic medication within 8 weeks before screening).
- •Body Mass Index: 18.0~35.0 kg/m2 (both inclusive)
排除标准
- •History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
- •More than 10% change in body weight within the 3 months before screening
- •Any laboratory test indicators meet the following standards:
- •fasting plasma glucose ≥ 15 mmol/L
- •aspartate aminotransferase, alanine aminotransferase levels > 3 times the upper limit of normal (ULN); total bilirubin > 1.5 times ULN
- •hemoglobin < 100 g/L
- •eGFR < 60 mL/min/1.73m2
- •fasting triglycerides > 5.64 mmol/L (500 mg/dL)
研究组 & 干预措施
Janagliflozin 25mg
Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
干预措施: Janagliflozin 25mg (Drug)
Janagliflozin 50mg
Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
干预措施: Janagliflozin 50mg (Drug)
Placebo/Janagliflozin
In the core period, each patient will receive placebo once daily for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin once daily until Week 52.
干预措施: Placebo/Janagliflozin (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24
时间窗: Baseline and Week 24
To examine whether the mean change in HbA1c from baseline to week 24 with Janagliflozin is superiority (superiority margin of 0.5%) to placebo
次要结局
- Change in HbA1c From Baseline to Week 52(Baseline and Week 52)
- Percentage of Patients With HbA1c <7% at Week 24 (Core period) and week 52(Baseline, Week 24 and week 52)
- Change in Fasting C-peptide From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Change in β-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Change in 2-hour Post-prandial Glucose From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Change in Blood Lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Change in Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Change in Blood Pressure (systolic blood pressure and diastolic blood pressure) From Baseline to Week 24 (Core period) and Week 52 (Extension period)(Baseline, Week 24 and Week 52)
- Percentage of Patients Who Have Received Rescue Therapy at Week 24 (Core period) and Week 52 (Extension period)(Week 24 and Week 52)