CTRI/2017/02/007763已完成3 期
A Prospective, Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III study to Compare the Efficacy, Safety and Immunogenicity of Premixed Human Insulin Biphasic (30% human insulin soluble injection and 70% human insulin isophane suspension) injectable suspension of MJ Biopharm Private Limited with Huminsulin® 30/70 in treatment of patients diagnosed with type 2 diabetes mellitus
MJ Biopharm Private Limited0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
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
- •Patients eligible for enrolment in the study must meet all of the following criteria:
- •1.Male or female patients 18 to 65 years of age (both inclusive)
- •2.Patients who have been diagnosed with T2DM for at least 1 year prior to baseline visit
- •3.Patients have been receiving a stable dose of premix human insulin biphasic 30/70 (30% human insulin soluble injection and 70% human insulin isophane suspension) for at least 3 months prior to baseline visit
- •4.Patients with glycated haemoglobin level <= 11 % at screening
- •5.Patients willing to provide signed written informed consent
- •6.Patients willing to comply all aspects of the protocol
- •7.Ability to self-inject insulin and perform SMBG measurements. Patients whose injection is being administered by caregiver/family member (only in the case wherein the patient has fear to self-inject or does not prefer to self-inject) will be enrolled
排除标准
- •Patients meeting any of the following criteria must not be enrolled:
- •1.Patients with history or evidence of hypersensitivity to insulin or its excipients
- •2.Patient who has received/receiving insulin of animal origin
- •3.Patient with history or evidence of recurrent severe hypoglycaemia within 6 months at baseline visit
- •4.Patients with uncontrolled T2DM, diabetic ketoacidosis requiring hospitalization within 6 months at baseline visit
- •5.Patients with use of insulin pump within 6 months at baseline visit
- •6.Patients whose requirement for total daily dose of insulin is > 1 IU/kg
- •7.Patients with serum AIA level above 20 U/mL
- •8.Patientâ??s having the any of the following laboratory results at screening
- •a.BUN > 30 mg/dL
- •b.ALT/AST levels >= 2.5 X ULN of the normal laboratory range
- •c.Serum creatinine level >2.0 mg/dL
- •9.Patients who have positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections
- •10.Patients receiving glucagon-like peptide 1 mimetics (GLP-1)
- •11.Patients receiving treatment with thiazolidinedione (TZD) within the last 3 months at baseline visit
- •12.Women of childbearing potential not willing to use acceptable method of contraception
- •13.Women who are pregnant or nursing mothers
- •14.Patients with body mass index (BMI) <18 kg/m² and >= 40 kg/m² at screening
- •15.Patients who have undergone pancreatectomy or pancreas islet transplant or renal transplant
- •16.Patients receiving or have received within the last year any immunomodulation medications that would possibly modify antibody generation either at the enrollment or during the course of the study
- •17.Patients who have received/receiving ( > 14 consecutive days) glucocorticoids within 4 weeks prior to baseline visit
- •18.Patients with history or evidence of diabetic complications (diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy), other complications related to T2DM other than those mentioned, or cardiac disorders, etc. which in the opinion of the investigator signifies patientsâ?? ineligibility for the trial
- •19.Patients with alcohol or drug abuse or any other medical or surgical condition, including lifestyle (e.g. shift workers, irregularity with meal times, etc.) that in the opinion of investigator can interfere with the study protocol or affect patientâ??s safety in the study
- •20.Has participated in any other clinical trial 6 months before the study entry
研究者
相似试验
招募中
3 期
A Prospective Multicenter Randomized Double blind Parallel group Active controlled Phase III Study to Compare the Efficacy Safety and Immunogenicity of Regenix Biosciences Limited India Insulin Glargine 100 units mL U100 with Lantus of Sanofi aventis IndiaCTRI/2023/10/059222Regenix Biosciences Limited
已完成
不适用
This is a clinical trial to compare clinical efficacy, safety and tolerability of generic Diclofenac Sodium Topical Gel 1%, with Voltaren® Gel (a Diclofenac Sodium Topical Gel 1%) and Vehicle of Diclofenac Sodium Topical Gel 1% in subjects with osteoarthritis(degenerative joint disease) of the kneeCTRI/2015/09/006149Cipla Limited990
招募中
不适用
To Evaluate the Efficacy and Safety of Berberis aristata in Adult Human Subjects who are suffering from Mild Cognitive ImpairmentCTRI/2022/08/045067Omniactive Health Technologies Ltd
尚未招募
3 期
Effect of Eluxadoline in Comparison to Mebeverine for Treatment of Patients With Diarrhoea-Predominant Irritable Bowel SyndromeCTRI/2024/02/062593Sun Pharmaceutical Industries Limited
招募中
3 期
Study to Compare the Efficacy and Safety of GBR 200 (similar biologic of Trastuzumab) versus Innovator Trastuzumab both when given in combination with Paclitaxel in patients diagnosed with HER2 Positive Metastatic Breast CancerCTRI/2017/02/007892Glenmark Pharmaceuticals Ltd