A physiological study of the effect of alpha-MSH on glucose tolerance in people with type 1 diabetes

Monash University0 个研究点目标入组 22 人开始时间: 2022年6月14日最近更新: 2023年10月16日

适应症

试验速览

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•Type 1 diabetes with a confirmed diagnosis of at least 3 years' duration and a plasma or serum c-peptide of less than 0.1 nM.
•BMI equal or greater than 18 and less than 30kg/m2, with a stable body weight for at least three months prior to enrolment.
•Be able to read and understand the written information about the study and provide written consent to participate in it.

•Significant current or past medical or psychiatric history that, in the opinion of the investigators, would pose unacceptable risk
•Unwillingness or inability to follow the procedures outlined in the protocol
•History of sensitivity to any of the peptides, or components thereof, or a history of drug or other allergy that, in the opinion of the investigators, would pose unacceptable risk
•Clinically significant abnormalities in screening electrocardiogram (ECG) or blood tests which, in the opinion of the study physician, would pose unacceptable risk
•Current pregnancy or breast-feeding in female participants or, if sexually active and of childbearing potential, unwilling to use effective contraception for the duration of the study
•The participant has received an investigational product within the preceding 90 days, 5 half-lives or twice the duration of its biological effect (whichever is longer)
•Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening
•Poor venous access
•Unable or unwilling to wear a continuous glucose monitoring sensor for the duration of the study

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