NCT00757588已完成3 期
A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 455
- 试验地点
- 17
- 主要终点
- Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])
研究概览
简要总结
The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
- •If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
- •Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
- •Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
- •Body mass index of 45 kg/m² or lower
- •Fasting C-peptide level of 0.8 ng/mL or higher
排除标准
- •Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
- •History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- •Women of childbearing potential unable or unwilling to use acceptable birth control
- •Women who are pregnant or breastfeeding
- •Active liver disease
- •Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
- •Use of short- or rapid-acting insulin
- •Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
- •Congestive heart failure
- •Unstable or rapidly progressing renal disease
- •History of alcohol or drug abuse within the previous year
- •History of hemoglobinopathies
- •Unstable major psychiatric disorders
- •Immunocompromised status
研究组 & 干预措施
Saxagliptin, 5 mg + insulin
Experimental
Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
干预措施: Saxagliptin, 5 mg + insulin (Drug)
Placebo + insulin
Placebo Comparator
Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
干预措施: Placebo + insulin (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])
时间窗: Baseline to Week 24
Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use
次要结局
- Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)(Baseline to Week 24)
- Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)(Baseline to Week 24)
- Change From Baseline in 120-minute PPG Values During an MTT(Baseline to Week 24)
- Change From Baseline in Fasting Plasma Glucose Values(Baseline to Week 24)
- Percentage of Participants Achieving a Therapeutic Glycemic Response(Baseline to Week 24)
研究者
研究点 (17)
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