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 Limited14 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
This is a prospective, multicenter, 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 (MJBPL) with Huminsulin®30/70 in treatment of patients diagnosed with type 2 diabetes mellitus
The Primary Objective of the study is to compare the change in glycated haemoglobin A1c (HbA1c) level from baseline to end of 12 weeks in patients diagnosed with type 2 diabetes mellitus (T2DM) receiving premix human insulin biphasic 30/70 of MJBPL versus Huminsulin® 30/70.
To compare the change in glycated haemoglobin A1c (HbA1c) level from baseline to end of 24 weeks in patients diagnosed with type 2 diabetes mellitus (T2DM) receiving premix human insulin biphasic 30/70 of MJBPL versus Huminsulin® 30/70.
The secondary objectives of the study are to evaluate the following:
1. Immunogenicity of the investigational product
- Safety of the investigational product
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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.Patient’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 patients’ 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 patient’s safety in the study 20.Has participated in any other clinical trial 6 months before the study entry.
结局指标
主要结局
Change in HbA1c from baseline
时间窗: 12 Weeks and 24 weeks
次要结局
- Efficacy:(1.Proportion of patients with change in HbA1c)
研究者
研究点 (14)
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