Safety and efficacy of an oral insulin (Capsulin) in patients with early‐stage type 2 diabetes: a dose‐ranging phase 2b study

Article


New, R., Sukumar, R., Chaudhari, V., Bogus, M., Travers, G. and Namjoshi, G. 2023. Safety and efficacy of an oral insulin (Capsulin) in patients with early‐stage type 2 diabetes: a dose‐ranging phase 2b study. Diabetes, Obesity and Metabolism. 25 (4), pp. 953-960. https://doi.org/10.1111/dom.14922
TypeArticle
TitleSafety and efficacy of an oral insulin (Capsulin) in patients with early‐stage type 2 diabetes: a dose‐ranging phase 2b study
AuthorsNew, R., Sukumar, R., Chaudhari, V., Bogus, M., Travers, G. and Namjoshi, G.
Abstract

Aim
This randomised, twelve-week open-label study compared the pharmacodynamic properties of different dose of regular human insulin administered in capsule form twice daily.
Methods
100 persons (48 male, 52 female) with type 2 diabetes on metformin completed the study according to protocol. Mean (SD) age 48.5 (6.7) years, BMI 25.7 (2.8) kg/m2, HbA1c 8.10 (0.65) %. Subjects randomised on admission were assigned to one of three groups receiving 75iu BD of formulated regular insulin or 150iu insulin BD, or 300iu BD in enteric-coated capsules. Primary and secondary endpoints were change from baseline in HbA1c and FPG respectively. A total of 100 subjects from 15 different centres completed the study within protocol.
Results
The study met its primary clinical endpoint of a decrease in HbA1c ≥ 0.5% (least square mean decrease 0.52%; p = 0.004, median decrease 0.6) in the dose group receiving 150iu BD. In a subset of this population, with starting HbA1c values between 9 and 9.5%, an average decrease of 1.575% was seen. In the total population, least square mean decreases in HbA1c for groups 75iu BD and 300iu BD were -0.11% and -0.42% respectively. Mean change in FPG in the 150iu BD dose group was -18.8mg/dL (p = 0.017) and -14.8 and -2.7mg/dL for groups 75iu BD and 300iu BD respectively. A decrease of 20% for triglycerides (-40 mg/dL) was seen in the 150iu BD dose group . No significant increases in body weight were observed, and significant decreases in systolic blood pressure were seen in all groups. No serious treatment-related adverse events were recorded, and no incidence of hypoglycaemia was reported throughout the whole twelve-week study period.
Conclusions
Capsulin oral insulin administered twice per day at a dose of 150iu per capsule is safe, with no confirmed treatment-linked hypoglycaemic events, and results in significant decreases from baseline in HbA1c, Fasting Plasma Glucose and triglycerides.

Keywordsclinical trial ; drug development; glycaemic control; insulin therapy; phase 1-2 study; type 2; diabetes
Sustainable Development Goals3 Good health and well-being
Middlesex University ThemeHealth & Wellbeing
LanguageEnglish
PublisherWiley
JournalDiabetes, Obesity and Metabolism
ISSN1462-8902
Electronic1463-1326
Publication dates
Online09 Dec 2022
PrintApr 2023
Publication process dates
Deposited25 Nov 2022
Submitted25 Apr 2022
Accepted07 Nov 2022
Output statusPublished
Publisher's version
License
Copyright Statement

Copyright © 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Digital Object Identifier (DOI)https://doi.org/10.1111/dom.14922
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