A physiological study of the effect of alpha-melanocyte stimulating hormone (alpha-MSH) on glucose tolerance in people with type 1 diabetes

Phase 2

Completed

• Conditions: Type 1 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622000832774
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-14
• Study Completion: 2023-08-04
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified