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.
G Life Sciences India Pvt Ltd0 个研究点目标入组 278 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 278
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients are eligible for participation into the study if all of the following criteria are met:
- •Â· Insulin naïve male or female type II diabetes mellitus patient
- •Â· Age between 18 and 75 years.
- •Â· At least 12 months history of Type II Diabetes
- •Â· Inadequate glycemic control on stable doses of one or more
- •oral antidiabetics for more tah or equal to 3 months
- •Â· 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
- •Â· 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
- •· 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.
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