EUCTR2010-018354-12-DE进行中（未招募）不适用
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 - Not Available
Biocon S.A.0 个研究点目标入组 286 人开始时间: 2010年5月11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 insulin treatment within 6 months after diagnosis (confirmed by interview with patient)
- •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 228
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
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
- •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
- •18. Impaired
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