CTRI/2009/091/000098Other3 期
A Randomized, Active Controlled, Parallel Group, Multi-Center, Two Stage, Open Label, Study Comparing Safety and Immunogenicity of Insugen® R and Insugen® N with Actrapid® and Insulatard® in Patients with Type 1 Diabetes Mellitus
Biocon S.A. Fid Borruat Sarl, Sous Maichereux 20 Case postale 2027 CH-2800, Delemont, Switzerland0 个研究点目标入组 274 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 274
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. Male and female patients between the ages of 18-80 years inclusive
- •3. Established diagnosis of T1DM for at least 1-year as per revised WHO criteria. Diagnosis of T1DM will be based on fasting plasma C-peptide 0.2 pmol/ml and / or history of initiation of insulin treatment within 6 months after diagnosis
- •4. Body mass index of 18.5-34.99 kg/m2 inclusive
- •5. Stable weight with no more than 5 kg gain or loss within 3 months of screening (obtained by patient history)
- •6. Glycosylated hemoglobin (HbA1c) ≤ 11.0% inclusive at screening
- •7. On stable daily doses (10% daily) of insulin or an insulin analogue for at least 3 months that requires two or more daily injections
- •8. Ability and willingness to perform blood glucose profiles using blood glucose meter at home during the study. Ability to perform blood glucose will be based on a completed 7-point glucose profile as described in Appendix C obtained over a single 24-hour period during the screening phase
排除标准
- •1. History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products
- •2. Patient with a clinically significant abnormality (including laboratory values) at screening, on the basis of which the Investigator advises against study inclusion
- •3. An ECG abnormality at screening considered clinically significant by the Investigator
- •4. Use of insulin pump therapy in the past 2 months prior to screening
- •5. Insulin resistance defined as requiring insulin of 1.4 IU/kg/day
- •6. Significant history of atopy or allergic drug reactions
- •7. Clinically significant major organ disease prior to screening, except for well-controlled and stable conditions such as essential hypertension (blood pressure <130/80 mmHg), and well controlled hyperlipidemia for at least 3 months prior to screening
- •8. Evidence of severe secondary complications of diabetes (e.g. active proliferative retinopathy, severe peripheral vascular disease, nephropathy, neuropathy or diabetic retinopathy treated with laser coagulation / vitrectomy within 6 months of the screening visit)
- •9. Unstable coronary artery disease (unstable angina, myocardial infarction within the preceding 6 months), heart failure (NYHA Grade 2 or higher), history of stroke within the preceding 6 months
- •10. History of drug or alcohol dependence or abuse within 6 months prior to screening
- •11. Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control
- •12. Patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study
- •13. History of two or more severe episodes of hypoglycemia (defined by ADA criteria) within 6 months prior to screening
- •14. Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening
- •15. Any electively planned surgery requiring hospitalization
- •16. Pregnancy, lactation, or planned pregnancy during the study duration. Women of childbearing potential (any women who is not surgically sterile or > 2 years post menopause) must give consent for using 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, but followed for pregnancy outcome
- •17. Impaired hepatic function (ALT or AST value greater than 2 times of upper limit of normal and/or serum bilirubin >1.5 times of upper limit of reference range at the screening visit)
- •18. Impaired renal function (serum creatinine ≥1.5 times of upper limit of reference range at screening)
- •19. Hemoglobinopathies, hemolytic anemia, anemia of chronic disease, or any factor affecting the measurement of HbA1c
- •20. The patient has received another investigational drug within 6 weeks prior to screening or within 5 half-lives of the drug, whichever is longer, or is scheduled for treatment with another investigational drug during the current study period
研究者
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