NCT00272012已完成3 期
Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone
适应症
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
- 396
- 试验地点
- 1
- 主要终点
- Change in HbA1c.
研究概览
简要总结
Primary objective:
The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.
Secondary objective:
Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:
- Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)
- Change of fasting plasma glucose (baseline to endpoint)
- Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint
- Insulin dose (rapid-acting, basal and total daily doses)
- Weight, body-mass index
- Hypoglycemic events
- Adverse events
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months
- •Pre-screening HbA1c value greater/equal 7% - smaller/equal 9%
- •FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l)
- •Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
- •Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home
排除标准
- •More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II
- •Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation)
- •Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- •Known impaired hepatic and renal function
- •History of drug or alcohol abuse
- •History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation
- •Treatment with any investigational drug in the last month before visit I
- •Pregnant or breast-feeding women, or women planning to become pregnant during the study
- •Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •Night shift workers if they are unable to comply with the treatment regimen
结局指标
主要结局
Change in HbA1c.
时间窗: from baseline to study endpoint.
次要结局
- Change of pre-, 2 h postprandial and nocturnal blood glucose values(8-point profile)
- Fasting blood glucose(8-point blood glucose profile values)
- Responder rate HbA1c smaller 7 %(at study endpoint)
- Insulin dose(rapid-acting, basal and total daily doses)
- Weight, BMI(study follow-up)
- Hypoglycemic events(study follow-up)
- Adverse events.(study follow-up)
研究者
研究点 (1)
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