CTRI/2011/11/002173招募中4 期
An Open Label, Randomized, Comparative Trial of the Safety and Efficacy of Wockhardtâ??s Insulin analogue Glargine (Glaritus®) with Sanofi Aventis Insulin analogue Glargine (Lantus®) given along with meal time bolus of rapid acting insulin (Lispro) in Type 1 diabetic patients. - SEGLAR
Wockhardt Ltd0 个研究点目标入组 322 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 322
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. Subjects, who at the time of screening, have fasting C-peptide < 0.5 nmol/L and have been on an insulin regimen for at least 12 months prior to inclusion in the trial.
- •2. Subjects with glycosylated hemoglobin (HbA1c) levels between 8 and 10%.
- •3. Subjects with body mass index (BMI) 18.0 to 38.0 kg/m2.
- •4. Subjects who understand nature of trial & provide written informed consent.
- •5. Subjects who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
- •6. Female subjects who are not pregnant and not lactating. Females subjects of childbearing potential must agree to use an acceptable method of birth control (including barrierâ??method contraceptives or intrauterine device). Women with history of bilateral tubal ligation, women who have undergone total hysterectomy or women who are post-menopausal for atleast 2 years are eligible (if within >= 18 and <= 55 years age).
- •7. Ability to use the self glucose-monitoring device and to self administer insulin.
排除标准
- •1. A subject with impaired hepatic function, where liver enzymes (AST or ALT) levels are abnormal and are clinically significant as assessed by the Investigator, however not 3 times the upper limit of normal range.
- •2. A subject with impaired renal function, where serum creatinine 2.0 mg/dl and/or BUN 30 mg/dl.
- •3. A subject with serum AIA result 0.95 index value (i.e., â??Borderlineâ?? or â??Positiveâ??).
- •4. A subject who is Hepatitis B or C or HIV positive.
- •5. A subject who is in a hyperthyroid or hypothyroid state will be excluded from the study. However, earlier diagnosed subjects (with a history of hyperthyroidism or hypothyroidism) who are well controlled on treatment (Euthyroid) can be considered for enrollment in the study.
- •6. A Subject whose requirement for total daily dose of insulin is 1.4 units/kg.
- •7. A subject with history or evidence of allergy to insulin preparations.
- •8. A subject with history or evidence of recurrent severe hypoglycemia.
- •9. A subject who has received any insulin of animal origin during the last 3 years.
- •10. A subject who is currently receiving or has received, within the last year, any immunomodulator medications, including corticosteroids that would possibly modify antibody generation either at the enrollment or during the course of the study. Topical / ophthalmic / intra-articular / nasal spray corticosteroids will be allowed.
- •11. A subject who has received an oral hypoglycaemic agent within 4 weeks prior to screening.
- •12. A subject with history or evidence of active severe proliferative retinopathy, nephropathy and/or neuropathy significant cardiovascular disease, anemia or hemoglobinopathy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment.
- •13. A subject who has undergone pancreatectomy or pancreas/islet cell transplant.
- •14. A subject who has been treated with other investigational agent or devices within the previous 30 days.
- •15. A subject who is unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
- •16. A subject who is an employee of the Investigator, or a subject who has a direct involvement with the trial or other trials under the direction of the Investigator.
- •17. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
研究者
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