Highlights
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Goals
This twelve-week, open-label, randomized study compared the pharmacodynamic properties of different doses of regular human insulin administered in capsule form twice daily.
Methods
100 people (48 men, 52 women) 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 randomized at entry were assigned to one of three groups receiving 75 IU BD of formulated regular insulin or 150 IU of BD insulin, or 300 IU BD in enteric-coated capsules. The primary and secondary endpoints were change from baseline in HbA1c and FPG, respectively. A total of 100 subjects from 15 different centers completed the study within the protocol.
Results
The study met its primary clinical endpoint of a decrease in HbA1c ≥ 0.5% (least squares mean decrease 0.52%; p = 0.004, median decrease 0.6) in the 150 IU dose group BD.
In a subset of this population, with baseline HbA1c values between 9 and 9.5%, an average decrease of 1.575% was observed. In the total population, the least squares mean decreases in HbA1c for the 75 IU BD and 300 IU BD groups were -0.11% and -0.42%, respectively.
The mean change in FPG in the 150 IU BD dose group was -18.8 mg/dL (p = 0.017) and -14.8 and -2.7 mg/dL for the 75 IU BD and 300 IU BD, respectively. A 20% decrease was observed for triglycerides (-40 mg/dL) in the 150 IU BD dose group.
No significant increases in body weight and significant decreases in systolic blood pressure were observed in all groups.
No treatment-related serious adverse events were recorded, and no incidence of hypoglycemia was reported throughout the twelve-week study period.
Conclusions
Capsulin oral insulin administered twice daily at a dose of 150 iu per capsule is safe, with no confirmed treatment-related hypoglycemic events, and produces significant decreases from baseline in HbA1c, fasting plasma glucose, and triglycerides.
