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

New, Roger ORCID logoORCID:, Sukumar, R., Chaudhari, Varsha, Bogus, Michal, Travers, Glen N. and Namjoshi, Gajanan (2023) Safety and efficacy of an oral insulin (Capsulin) in patients with early‐stage type 2 diabetes: a dose‐ranging phase IIb study. Diabetes, Obesity and Metabolism, 25 (4) . pp. 953-960. ISSN 1462-8902 [Article] (doi:10.1111/dom.14922)

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This randomised, twelve-week open-label study compared the pharmacodynamic properties of different dose of regular human insulin administered in capsule form twice daily.

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.

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.

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.

Item Type: Article
Sustainable Development Goals:
Keywords (uncontrolled): Endocrinology, Endocrinology, Diabetes and Metabolism, Internal Medicine
Research Areas: A. > School of Science and Technology
Item ID: 36839
Notes on copyright: 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.
Depositing User: Jisc Publications Router
Date Deposited: 25 Nov 2022 16:47
Last Modified: 16 Mar 2023 12:00

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