NCT00135096已完成3 期
APIDRA® (Insulin Glulisine) Administered Premeal vs Postmeal in Adult Subjects With Type 2 Diabetes Mellitus Receiving LANTUS® (Insulin Glargine) as Basal Insulin: a Multicenter, Randomized, Parallel, Open Label Clinical Study
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
- Sanofi
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Compare change in weight from baseline to study week 52 in the per-protocol population of premeal Apidra vs postmeal Apidra, in patients receiving Lantus as basal insulin
研究概览
简要总结
The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus for at least six months
- •18 to 70 years of age, inclusive
- •A1c ≥ 7.5% and ≤ 10%
- •At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections per day) +/- metformin prior to study entry
- •Negative glutamic acid decarboxylase (GAD) autoantibodies
- •Ability and willingness to perform self-monitoring of blood glucose (SMBG) at least four times a day, and at least 7 times daily during the 7-point blood glucose (BG) profile measurement days
- •Ability and willingness to adhere to, and be compliant with, the study protocol
- •Must be able to read English or Spanish at the sixth grade level in order to complete the patient-reported outcomes component of the study
- •Signed informed consent
排除标准
- •Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with or without metformin
- •Planned pregnancy; or pregnant or lactating females
- •For subjects treated with metformin: serum creatinine ≥ 1.5 mg/dL (133 µmol/L) for males or ≥ 1.4 mg/dL (124 µmol/L) for females
- •Serum creatinine ≥ 3.0 mg/dL (266 µmol/L)
- •Any clinically significant renal disease (other than proteinuria) or hepatic disease
- •Serum ALT or AST levels greater than 2.5 X the upper limit of normal
- •Any current malignancy or any cancer within the past 5 years (except for adequately treated basal cell skin cancer or cervical carcinoma in situ)
- •Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Diagnosis of impaired dexterity or vision rendering the subject unable to administer multiple daily injections (MDIs)
- •Cardiac status New York Heart Association (NYHA) III-IV
- •Hypersensitivity to Lantus or Apidra or any of their components
- •Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study.
- •Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- •Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
研究组 & 干预措施
1
Experimental
PREMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day 0-15 min before the three main meals; metformin (if applicable); and Lantus qd for 52 weeks.
干预措施: insulin glulisine (Drug)
2
Experimental
POSTMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day immediately after a meal (20 min after the start of a meal); metformin (if applicable); and Lantus qd for 52 weeks.
干预措施: insulin glargine (Drug)
结局指标
主要结局
Compare change in weight from baseline to study week 52 in the per-protocol population of premeal Apidra vs postmeal Apidra, in patients receiving Lantus as basal insulin
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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