CTRI/2024/07/071182已完成3 期
A Randomized, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Rapilin 30 (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension) Injection with NovoMix 30 (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension) Injection in Adult Patients of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 13
- 主要终点
- Change in HbA1c value
研究概览
简要总结
This study is designed to compare the efficacy, safety, and immunogenicity of Rapilin 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection with NovoMix 30 (30% insulin aspart and
70% insulin aspart protamine suspension) injection in adult patients with T2DM. This phase 3 study is of 6 months duration inclusive of the immunogenicity testing on 288 subjects. Thus, the rationale for this
study is to generate the necessary data on the efficacy, safety, and immunogenicity of Rapilin 30 (30% insulin aspart and 70% insulin aspart protamine suspension) Injection as compared to the reference
product, NovoMix 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection in adult patients with T2DM for seeking marketing authorization in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients between the ages of 18 to 65 years, both ages inclusive, who have provided written informed consent for participation in the study and willing to comply with study procedures.
- •Patients with an established diagnosis of T2DM and a duration of diabetes mellitus of at least 6 months at screening visit.
- •HbA1c between 7.5%.
- •10.0% (both values inclusive).
- •BMI of ≤ 40.0 kg/m
- •Patients treated with premix human insulin (one or more insulin injections) for at least 3 months prior to the screening visit
- •Insulin Aspart/Insulin Aspart mixes’ naïve patients
- •Current treatment with up to 3 OADs/without OADs; in case of patients on OADs unchanged dosing for at least 3 months prior to the screening visit.
- •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.
- •Willingness and ability to self-inject insulin (2 injections daily), perform self-monitoring of blood glucose (SMBG) testing, and keep record in the patient diary.
排除标准
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the day of screening.
- •Known or suspected hypersensitivity to insulin or related product(s).
- •Patients on insulin analogs (other than premix human insulin).
- •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 study data.
- •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.
- •Impaired liver function, defined as alanine transaminase ≥ 2.5 times upper limit of normal.
- •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).
- •Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
- •Patients who have active proliferative retinopathy or macular edema.
- •Known/screening seropositive patients of human immunodeficiency virus (HIV) or hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •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
Change in HbA1c value
时间窗: From baseline to end of 12 weeks and from baseline to end of 24 weeks
次要结局
- - Change in the FPG(- Change in the post-prandial blood glucose)
研究者
Dr Rajeev Chawla
North Delhi Diabetes and Cardiac Centre
研究点 (13)
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