Research on Human Insulin rDNA (Insuget) Safety and Efficacy in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Frequency of adverse events, serious adverse events during the course of study follow-up
研究概览
简要总结
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus.
Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
Sample size: The estimated target sample size is n=230. Study duration: 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date)
After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy.
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Primary (SAFETY Outcomes):
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Frequency of adverse events during the course of study follow-up.
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Frequency of serious adverse events.
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SECONDARY OUTCOME MEASURES (EFFICACY ENDPOINTS)
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Change from baseline in HbA1c% to the last-observation.
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Change from baseline in fasting plasma glucose to the last- observation on treatment
Ethical consideration:
The ethical approval of study is taken from an independent ethics committee. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.
详细描述
OBJECTIVE To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus.
METHODOLOGY:
STUDY DESIGN:
Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
SAMPLE SIZE As per cited literature, the reported hypoglycemia rate was 41% in patients who underwent treatment of Human Regular Insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients who give written informed consent.
- •Type 2 diabetic males & females with age 18 & above years.
- •HbA1c: 7.0% and above.
- •Patients with uncontrolled Diabetes after intervention of lifestyle modifications plus oral and/or insulin therapy.
排除标准
- •Known type 1 diabetes mellitus patients.
- •History of severe hypoglycemia (<70mg/dL)
- •History of hypersensitivity to any of the active or inactive ingredients of the insulin preparations used in the trial, and/or history of significant allergic drug reactions.
- •Presence of severe diabetes complications.
- •History of renal and/or hepatic dysfunctions.
- •Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- •History of acute coronary syndrome or stroke.
- •Pregnant or lactating females.
- •History of Acute psychiatric disorder or exacerbation of chronic psychiatric disorder.
- •History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
研究组 & 干预措施
Uncontrolled diabetes requiring Insulin
干预措施: Insulin (Drug)
结局指标
主要结局
Frequency of adverse events, serious adverse events during the course of study follow-up
时间窗: 6 months
Drug safety
Change from baseline in HbA1c% to the last-observation
时间窗: 6 months
Drug efficacy
Change from baseline in fasting plasma glucose to the last- observation on treatment
时间窗: 6 months
Drug efficacy
次要结局
未报告次要终点