A double-blind, randomized, clinical study with a single subcutaneous dose to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of two Regular recombinant human insulins, the test drug being the Regular Human Insulin produced by Bioton SA and the reference medicine Humulin® R produced by Eli Lilly Brasil Ltda using euglycemic and hyperinsulinemic clamp technique in type 1 diabetic research participants (PPES005/17)

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.0 个研究点开始时间: 2018年2月6日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Be between 18 and 65 years old, inclusive;have been diagnosed with type 1 diabetes for at least 1 year;body Mass Index (BMI) between 18 and 30 kg / m2;being on insulin therapy;have basic knowledge of the disease that allows self-adjustment of the insulin dose according to the algorithm described in the protocol;h have positive anti-GAD antibody or anti-IA2 antibody positive or C-peptide levels less than 0.5ng / mL (0.2 mmol / L);participants should be free of any detectable micro- and macroangiopathic complications that are clinically significant at the discretion of the investigator and any major disease other than diabetes as indicated by medical history, physical examination, electrocardiogram, or routine laboratory exams

•Type 2 diabetes;use of any oral hypoglycemic;any factor that opposes the inclusion criteria; pregnant or lactating women who are breastfeeding; participants in the use of glucocorticoids or any other medication that may interfere with glycemic control, at the discretion of the investigator; any concomitant medical condition that may interfere with the performance of the protocol, including but not limited to clamp; participant with chronic hepatopathy, chronic renal failure, renal insufficiency, congestive heart failure grade II or above; history of cancer in the last 5 years;participant with indication for any surgical procedure in the next 6 months;h history of major surgery in the last 6 months.

发起方

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.