CTRI/2010/091/000627已完成3 期
A Randomized, Active Controlled, Parallel Group, Multicentre, Two-Phase, Open-Label Study Comparing the Safety and Immunogenicity of Insugen R and Insugen N with Actrapid and Insulatard in Patients with Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocon SA
- 入组人数
- 286
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. Provide written informed consent
- •2. Patients between the ages of 18 to 80 years
- •3. T1DM patients diagnosed with in the last 1 year.
- •4. Patients on basal-bolus insulin therapy
- •5. Body mass index of 18.5 to 34.99 kg/m2
- •6. Stable weight
- •7. Glycosylated haemoglobin of less than or equal to 11.0 percentage
- •8. Ability and willingness to comply with the protocol
排除标准
- •1.History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products
- •2.Significant history of atopy or allergic drug reactions
- •3.Use of insulin pump therapy
- •4.Moderate insulin resistance
- •5.A clinically significant laboratory abnormality on the basis of which the Investigator advises against study inclusion
- •6.Clinically significant disease, except for well-controlled hypertension, hyperlipidaemia and thyroid disorders which as per the investigator makes the patient unsafe to be included in the study
- •7.Complications of abnormal glucose control and secondary complications of diabetes
- •8.An electrocardiogram abnormality considered clinically significant by the Investigator
- •9.History of drug or alcohol dependence or abuse within 6 months before Screening
- •10.Use of medications that can affect sugar control
- •11.Any electively planned surgery requiring hospitalization
- •12.Pregnancy, breastfeeding, or planned pregnancy during the study duration. Women of childbearing potential (any woman who is not surgically sterile or more than 2 years post menopause) must agree to use a reliable method of contraception (e.g., double-barrier, tubal ligation, or stable hormonal contraception) throughout the study period. Women who become pregnant during the study must be discontinued from the study and followed for pregnancy outcome
- •13.Hematological disorders
- •14.Receipt of another investigational drug within 6 weeks before Screening or within 5 half-lives of the drug, whichever is longer, or scheduled treatment of another investigational drug during the current study period
研究者
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