CTRI/2013/01/003289已完成3 期
Safety and Efficacy of Exenatide Injection in Subjects with Type 2 Diabetes Mellitus: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multicentric, 24 Week Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
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
- •1.Male and female subjects 20 years of age and older.
- •2.Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
- •3.Weight stable
- •4.Women of child-bearing potential must be practicing an acceptable method of birth control as judged by the investigator
- •5.Willing to participate and give written informed consent.
排除标准
- •1.Previous exposure to exenatide
- •2.Current or previous exposure to insulin.
- •3.Used drugs for weight loss
- •4.Currently treated with any of the excluded medications
- •5.Received treatment within the last 3 months with a drug that has not received regulatory approval for indication at the time of trial entry
- •6.Type 1 diabetes mellitus.
- •7.Severe renal impairment
- •8.A history of renal transplantation or currently on renal dialysis.
- •9.History of pancreatitis.
- •10.A known allergy to any components contained in the exenatide injection.
- •11.A history of severe gastrointestinal disease
- •12.Pregnant or lactating females
- •13.History of chronic pancreatitis
- •14.Immunosuppressed or requiring treatment with an immunosuppressant or recently received an immunosuppressant, including systemic corticosteroids.
- •15.History of immune deficiency syndrome or HIV positive
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