CTRI/2010/091/000012已完成3 期
A prospective, multicentre, comparative, open label, randomised parallel phase III study to assess efficacy and safety of recombinant insulin glargine compared with Lantus® in patients with Type II Diabetes Mellitus uncontrolled on OAD therapy.
LG Life Sciences India Pvt Ltd10 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2010年10月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 10
- 主要终点
- Efficacy: Change in HbA1c from
研究概览
简要总结
This is a prospective, multicentre, comparative, open label, randomised parallel phase III clinical study with primary objective to assess efficacy and safety of recombinant insulin glargine compared with Lantus® in patients with Type II Diabetes Mellitus uncontrolled on Oral Anti-Diabetic therapy, that will be conducted in nine investigator sites in India.The secondary outcome will be To compare test drug and Lantus® with respect to the (a) Glycemic control as determined by self monitored blood glucose concentrations (b) Change from baseline to endpoint in fasting blood glucose; and (c) Incidence of Hypoglycemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients are eligible for participation into the study if all of the following criteria are met: · Insulin naïve male or female type II diabetes mellitus patient · Age between 18 and 75 years.
- •Â· At least 12 months history of Type II Diabetes · Inadequate glycemic control on stable doses of one or more oral antidiabetics for more tah or equal to 3 months · HbA1c between 7.5 to 10 %.
- •Â· FBG more than or equal to 126 mg/dl, and less than 234 mg/dl.
- •Â· Body Mass Index less than or equal to 40 kg/m2 · Willing and able to measure Fasting Blood Glucose by blood glucose meter and 8-time point blood glucose within 24 hours, once before every visit.
- •Â· Willing and able to give informed consent and comply with study procedures.
排除标准
- •Type I Diabetes Mellitus· Prior use of insulin except for gestational diabetes or for less than or equal to 1 week· Pancreatitis or Pancreatectomy· History of ketoacidosis· Clinically relevant cardiovascular, hepatic, neurological, endocrine, gastrointestinal, urinary,reproductive or other major systemic diseases· Impaired renal function with serum creatinine greater than or equal to 1.5 mg/dl· Impaired hepatic function as shown by ALT or AST greater than twice the upper limit of normal· Proliferative diabetic retinopathy.· Use of other agents affecting glycemic control (non-selective beta- blockers, weight loss agents.)· History of myocardial infarction· Female patient who is pregnant, wishes to become pregnant during study period, or is breastfeeding..
- •Recent history (within 60 days) or likely future use of systemic glucocorticosteroids or other immunosuppressant or cytotoxic therapy.· Self reported inability to recognize hypoglycemia· Being a night shift worker· Participation/Treatment with any investigational drug or biologic in a clinical study within the past 30 days.· History of drug or alcohol abuse.· Any other condition which, in the judgment of the investigator, makes the patient unsuitable to participate in the study.
结局指标
主要结局
Efficacy: Change in HbA1c from
时间窗: Efficacy: 24 Weeks
baseline to treatment period.
时间窗: Efficacy: 24 Weeks
次要结局
- Efficacy:Mean blood glucose in two treatment groups (8 time-point BG value per 24 hrs)(24 Weeks treatment period)
- Change in FBG from baseline to endpoint in the two treatment groups.(24 weeks treatment period)
- Hypoglycemic incidence rate in the two treatment groups(24 weeks treatment period)
研究者
研究点 (10)
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