CTRI/2022/06/043563招募中4 期
A Prospective, Open-Label, Randomized, Parallel Group, Comparative, Multi-center, Phase IV Trial to Evaluate the Immunogenicity and Safety of Wockhardt’s Basal or Bolus human insulin (Wosulin R, Wosulin N and Wosulin 30/70) with Eli Lilly’s Basal or Bolus human insulin (Huminsulin R, Huminsulin N and Huminsulin 30/70) in Subjects with Diabetes Mellitus
Wockhardt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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
- •1.Adult Subjects of 18 years age and above
- •2.Subjects who have been diagnosed with either type 1 or type 2 Diabetes Mellitus
- •3.Subjects with HbA1c levels = 7% & = 10%
- •4.A. T1DM patients diagnosed at least for 12 months receiving stable insulin regimen (recombinant human insulin or analogs) for 6 months before screening who can be shifted to study basal bolus regimen of premixed insulin (insulin 30/70) & regular insulin (insulin R) according to investigator as standard of care (A stable insulin regimen is define as the insulin dose within +/- 10%)
- •B. T2DM insulin naïve patients uncontrolled on oral antidiabetic drugs (OADs) requiring human premixed insulin (insulin 30/70) according to investigator as standard of care
- •C. T2DM insulin naïve patients uncontrolled on oral antidiabetic drugs (OADs) requiring basal human insulin NPH (insulin N) according to investigator as standard of care
- •D. T2DM patients uncontrolled on oral antidiabetic drugs (OADs) and Lantus (basal insulin glargine) who may have received Lantus at least for 3 months and requiring human regular insulin (insulin R) to be added according to investigator as standard of care.
- •5.Subjects who are co-operative and agree to have regular injections of insulin and are willing to comply with protocol procedures.
- •6.Ability to use the self-glucose-monitoring device and to self- administer insulin and willing to record FBG & PPBG values and the insulin dose in a subject diary
- •7.Subjects who understand the nature of trial and provide written informed consent for the trial
排除标准
- •1.Women of child-bearing potential who are pregnant or lactating or not following adequate contraceptive measures.
- •2.Subjects with secondary diabetes or maturity-onset diabetes
- •3.History or evidence of allergy to insulin preparations
- •4.History or evidence of severe hypoglycemia (characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycemia) in last six months from day of consenting
- •5.Currently receiving or has received any immunomodulator medications including corticosteroids (except topical corticosterioids) that would possibly modify antibody generation.
- •6.Any medical condition that in the opinion of Investigator can interfere with the study treatment.
- •7.Presence of Hepatitis B or C or human immunodeficiency virus (HIV) positive status
- •8.A subject who has been treated with other investigational agent or devices within the previous 30 days of screening.
- •9.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
研究者
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