A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Chinese Subjects in China With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination With Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 953
- 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
A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination with Metformin
详细描述
Study Design: Randomized, prospective, double-blind, two-arm, parallel group, multi-center trial.
Target Subject Population: Subjects aged ≥18 who have type 2 diabetes (HbA1c of ≥7.5% and ≤11.0% and FPG<270 mg/dL (15 mmol/L)) on stable baseline therapy (insulin alone or insulin combined with metformin, with insulin at doses of ≥20 and ≤150 units per day total) for at least eight weeks at the time of screening. Insulin may be long-acting, intermediate-acting, or pre-mixed. 444 patients are planned to be randomized.
Investigational Product, Dosage and Mode of administration: Active treatment will comprise Saxagliptin 5 mg tablets once daily.
Comparator, Dosage and Mode of administration: Matching placebo tablets will be used as comparator.
Duration of Treatment: The study is divided to a single blind placebo lead in period of 8 weeks and a double-blind treatment phase of 24 weeks. Patients will be rescued based on high FPG values.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent before participating in the study.
- •Diagnosed with type 2 diabetes.
- •Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG<270 mg/dL (15mmol/L). At Day -4 visit, HbA1c ≥7.5% and ≤10.5%. and FPG<270 mg/dL (15mmol/L)).
- •On a stable dose of insulin for 8 weeks or longer prior to screening.
- •If taking metformin, subjects should have been taking the same daily dose for 8 weeks or longer prior to screening.
- •Insulin type should be intermediate-acting or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as one component).
- •Body mass index ≤45 kg/m^2.
排除标准
- •Women of childbearing potential unable or unwilling to use acceptable birth control.
- •Women who are pregnant or breastfeeding.
- •Symptoms of poorly controlled diabetes. including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms.
- •Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable clinical significant arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.
- •Congestive heart failure
- •Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled).
- •History of unstable or rapidly progressing renal disease.
- •History of alcohol or drug abuse within the previous year.
- •Unstable major psychiatric disorders.
- •History of hemoglobinopathies
- •Immunocompromised status
- •Severe liver disease.
- •In subjects treated with insulin alone a calculated creatinine clearance <50 ml/min. In patients treated with insulin in combination with metformin a calculated creatinine clearance <60 ml/min or serum creatinine > 1.5 mg/dL in males or > 1.4mg/dL in females.
研究组 & 干预措施
Saxagliptin 5mg
Saxagliptin 5mg, administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
干预措施: Saxagliptin 5mg (Drug)
Placebo
Placebo administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
干预措施: Placebo for Saxagliptin (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24
时间窗: Baseline to 24 weeks
次要结局
- Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test(Baseline to 24 weeks)
- Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%(At Week 24)
- The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)(Baseline to Average of Weeks 20 and 24)
- Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24(Baseline to 24 weeks)
- Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test(Baseline to 24 weeks)