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

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.

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