EUCTR2010-018354-12-HU进行中（未招募）不适用
A randomized, active controlled, parallel group, multi-center, two phase, open label study comparing safety and immunogenicity of Insugen R and Insugen N with Actrapid and Insulatard in patients with type 1 diabetes melllitus. - NA
Biocon S.A.0 个研究点目标入组 286 人开始时间: 2010年6月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provide written informed consent
- •2.Male and female patients between the ages of 18 to 80 years, inclusive
- •3.Patient must have been diagnosed with T1DM before 40 years of age and must have been on treatment with insulin for at least one year (confirmed by interview with the patient). Patients should have a fasting plasma C-peptide 4.At least 3 months on basal-bolus insulin therapy before enrolment requiring 3 or more daily injections
- •5.Body mass index of 18.5 to 34.99 kg/m2, inclusive
- •6.Stable weight with no more than 5 kg gain or loss within 3 months of Screening (obtained by patient history)
- •7.Glycosylated haemoglobin (HbA1c) = 11.0% at Screening. One (1) re-test is permitted within the Screening timeline, if required.
- •8.Ability and willingness to perform blood glucose profiles using blood glucose meter at home during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products
- •2.A clinically significant abnormality (including laboratory values) at Screening, on the basis of which the Investigator advises against study inclusion
- •3.An electrocardiogram (ECG) abnormality at Screening considered clinically significant by the Investigator
- •4.Use of insulin pump therapy in the past 2 months before Screening
- •5.Moderate 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 before Screening, except for well-controlled and stable conditions such as essential hypertension (blood pressure >130/80 mmHg), well controlled hyperlipidaemia, and thyroid disorders for at least 3 months before Screening.
- •8.Knowledge of secondary complications of diabetes:
- •a.Retinopathy: moderate to severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy of any severity or history of treatment with laser surgery/vitrectomy within 6 months of the Screening visit
- •b.Nephropathy: Proteinuria =1+ by urine dipstick in the absence of infection or vaginal contamination and/or serum creatinine =1.5 times of upper limit of reference range, one (1) re-test is permitted within the Screening timeline, if required; history of renal transplant
- •c.Neuropathy: History or finding of severe form of sensorimotor, cardiac, gastrointestinal, or genitourinary autonomic neuropathy
- •d.Peripheral vascular disease (PVD): Severe PVD that has resulted in amputation, chronic foot ulcer, claudication on walking <200 metres, or absent pulses
- •9.Unstable coronary artery disease (unstable angina, myocardial infarction within the preceding 6 months), heart failure (New York Heart Association Grade 2 or higher), history of stroke, or transient ischemic attack within the preceding 6 months
- •10.History of drug or alcohol dependence or abuse within 6 months before Screening
- •11.Current use of systemic or inhaled glucocorticoids or other drugs which may affect glycaemic control
- •12.Treatment with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks before Screening or during the study
- •13.The use of prohibited concomitant medications, including oral hypoglycaemic agents; monoamine oxidase (MAO) inhibitors; Beta blockers; salicylates >300 mg/day or chronic usage requiring uninterrupted administration for >14 days during the study; anabolic steroids; diltiazem; niacin; isoniazid; epinephrine; thiazide diuretics if >25 mg/day; and loop diuretics.
- •14.History of 2 or more episodes of hypoglycaemia requiring assistance by another person to administer glucose or glucagon (severe hypoglycaemia) within 6 months before Screening
- •15.Any hospitalisation or emergency department visit due to poor diabetes control within 6 months before Screening
- •16.Any electively planned surgery requiring hospitalisation
- •17.Pregnancy, breastfeeding, or planned pregnancy during the study duration. Women of childbearing potential (any woman who is not surgically sterile or > 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
- •18.Impaired hepatic function (alanine tran
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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 - NDDiabetes Mellitus Type 1MedDRA version: 9.1Level: LLTClassification code 10045228EUCTR2010-018354-12-ITBIOCON S A286