Cross-over, double-blind, randomized, single dose euglycemic hyperinsulinemic clamp study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of NPH recombinant human insulin produced by Biomm/Bioton and the reference product Humulin® N produced by Eli Lilly in type 1 diabetic patients (T1DM).

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.0 个研究点开始时间: 2018年1月31日最近更新: 2023年5月29日

研究概览

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•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 doseaccording to the algorithm described in the protocol;Have positive antiGAD antibody or antiIA2 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

发起方

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.