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 Limited0 个研究点目标入组 320 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
- 320
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 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 mixesââ?¬• naive, daily for ïâ??³3 months prior to the screening visit.
- •3.Current treatment with/without OADs; in case of patients on OADs unchanged dosing for ïâ??³3 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) ââ?°Â¥18kg/m2and ââ?°Â¤ 40 kg/m2.
- •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 patientââ?¬•s safety, the patientââ?¬•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 ââ?°Â¥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.
研究者
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