CTRI/2019/04/018455已完成3 期
A Randomized, Open Label, Parallel-group, Multi-center Phase 3 Study to Compare Efficacy and Safety of Recombinant Insulin Aspart (Manufactured by BioGenomics Limited) with NovoRapid® (Manufactured by Novo Nordisk), in Adult Patients with Diabetes Mellitus
BioGenomics Limited27 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2019年4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
- 320
- 试验地点
- 27
- 主要终点
- To compare the efficacy of recombinant insulin aspart (manufactured by BGL) with
研究概览
简要总结
The proposed study is designedto compare the efficacy, safety and immunogenicity of insulin aspart [BGL] 100U/mL with NovoRapid® [manufactured by Novo Nordisk], in patients with Type2 (T2DM) diabetes mellitus.
This phase 3 study is for 6months inclusive of the immunogenicity testing including 320 subjects. It aimsto compare immunogenicity of insulin aspart [BGL] with NovoRapid® [manufacturedby Novo Nordisk], by testing the anti-insulin antibodies. The study gives adetailed comprehensive safety profile of insulin aspart [BGL] with referenceproduct NovoRapid® [manufactured by Novo Nordisk].
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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 who meet all of the following criteria will be included in the study: 1.Type 2 DM patients willing to give written informed consent and willing to take a maximum of 4 injections daily.
- •2.Patients with T2DM, diagnosed since at least 6 months, who have been treated with premix human insulin (one or more insulin injections), who are insulin aspart/insulin aspart mixes’ naive, daily for 3 months prior to the screening visit.
- •3.Current treatment with/without OADs; in case of patients on OADs unchanged dosing for 3 months prior to the screening visit.
- •4.HbA1c between 7.5% -10.0%, both inclusive.
- •5.Both sexes aged between 18 to 65 years.
- •6.Body Mass Index (BMI) ≥18kg/m2and ≤ 40 kg/m
- •7.Female patients who are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control.
- •8.Willingness and ability to self-inject insulin, perform SMPG, and keep record in the patient diary.
排除标准
- •Patients who meet any of the following criteria will be excluded from the study: 1.Known or suspected hypersensitivity to insulin or related product(s).
- •2.Previous participation in this trial (participation is defined as randomization).
- •3.Patients on insulin analogs (other than premix human insulin).
- •4.Patients who have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening or are likely to simultaneously participate in another therapeutic clinical study.
- •5.Patients with any other clinically significant disease(s) which, in the opinion of the Investigator could compromise the patient’s safety, the patient’s involvement in the study or overall interpretation of the trial data.
- •6.Cardiovascular disease such as stroke, unstable angina pectoris, myocardial infarction, coronary arterial bypass graft or angioplasty, congestive heart failure class III or IV as per New York Heart Association, within 6 months prior to screening.
- •7.Impaired liver function, defined as alanine transaminase ≥2.5 times upper limit of normal.
- •8.Patients who have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer).
- •9.Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
- •10.Patients who have active proliferative retinopathy or macular edema.
- •11.Known/screening seropositive patients of HIV or HBV or HCV.
- •12.Women of child bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and at least 1 week after the last visit.
结局指标
主要结局
To compare the efficacy of recombinant insulin aspart (manufactured by BGL) with
时间窗: From baseline to end of 12 weeks and from baseline to end of 24 weeks
NovoRapid® (manufactured by Novo Nordisk) by measuring Mean change in glycated haemoglobin (A1C) from Baseline to end of 12 weeks and from Baseline to end of 24 weeks
时间窗: From baseline to end of 12 weeks and from baseline to end of 24 weeks
次要结局
- Mean change in the fasting plasma glucose from baseline to end of 12 weeks and from baseline to end of 24 weeks Mean change in the post-prandial plasma glucose (after standard meal challenge) from baseline to end of 12 weeks and from baseline to end of 24 weeks(Proportion of patients who achieve target A1C (7%) between the treatment groups at the end of 12 weeks and 24weeks.)
研究者
研究点 (27)
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