Efficacy and Safety of Janagliflozin in Combination With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control With Metformin Alone
试验速览
- 阶段
- 3 期
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c (HbA1c) From Baseline to Week 24 (Core period)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Janagliflozin compared to placebo, both in combination with Metformin, in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with Metformin alone.
详细描述
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study (a 24-week core period followed by a 28-week extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo, all in combination with Metformin, in patients diagnosed with T2DM who are not achieving an adequate response from Metformin monotherapy. Approximately 390 patients with inadequate glycemic control with Metformin monotherapy will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg , both in combination with Metformin , for 52 weeks, or receive 24 weeks of double-blind treatment with placebo in combination with Metformin followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg, both in combination with Metformin. 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 Linagliptin (rescue therapy) consistent with local prescribing information.
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
- •T2DM Patients with inadequate glycemic control (HbA1c level≥7.0% and ≤10.5% at baseline) on metformin monotherapy.
- •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
Placebo/Janagliflozin plus metformin
In the core period, each patient will receive placebo plus metformin for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin plus metformin until Week 52.
干预措施: Placebo plus metformin (Device)
Janagliflozin 25 mg plus metformin
Each patient will receive 25 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period)
干预措施: Janagliflozin plus metformin (Drug)
Janagliflozin 50 mg plus metformin
Each patient will receive 50 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period)
干预措施: Janagliflozin plus metformin (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 24 (Core period)
时间窗: Baseline and Week 24
To examine whether the mean change in HbA1c from Baseline to Week 24 with Janagliflozin is superior to placebo
次要结局
- 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 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 Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)(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 HbA1c From Baseline to Week 52(Baseline 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 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 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)
- Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period) by calculation Homeostasis model assessment-insulin resistance(Baseline, Week 24 and Week 52)
- Percentage of Patients With HbA1c <7% at Week 24 (Core period) and Week 52 (Extension period)(Week 24 and week 52)
- Percentage of Patients Who Have Received Rescue Therapy at 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)