A Phase 2b, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects with Mild to Moderate Diabetic Peripheral Neuropathy

Cebix Incorporated0 个研究点目标入组 240 人开始时间: 2012年12月17日最近更新: 2020年6月2日

适应症

试验速览

暂无简介。

•Give informed consent;
•18 - 65 years old;
•Have type 1 diabetes mellitus for a minimum of 5 years (or 4 years with Investigator and Sponsor documented approval, based on patient’s presentation at screening), with a stable diabetic regimen (for at least 3 months) that provides adequate glucose control;
•Have clinical signs of diabetic peripheral neuropathy at screening;
•Have abnormal sural nerve conduction bilaterally during screening;
•Be C-peptide deficient;
•Be in good general health (besides having type 1 diabetes mellitus);
•Practice effective contraception during the study and for 12 weeks after study participation;
•Have a body mass index (BMI) =18.0 and <35.0 kg/m2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 234
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;
•Any condition that could mimic diabetic peripheral neuropathy or impair peripheral nerve function;
•Known or suspected hypersensitivity or allergic reaction to C-peptide or any of the excipients in CBX129801;
•Have unstable or inadequate glucose control;
•Any significant clinical laboratory value at screening;
•Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of the first dose of study drug, or recurrent episodes of non-severe hypoglycemia (= 3 per week on average) that are deemed clinically significant by the Investigator;
•Have had an islet cell, kidney, and/or pancreas transplant;
•If female, is pregnant or lactating;
•History of alcohol or substance abuse within 2 years;
•Positive screen for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
•Initiation of treatment or change of dose of medications that could affect peripheral nerve function within 60 days;
•Previous treatment with CBX129801 or unmodified C-peptide;
•Receipt of an investigational product or therapeutic device, or participation in a drug research study within a period of 30 days;
•Chronic use of oral steroids within 60 days.

发起方