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Repeat-dosing of oral insulin (Capsulin) in persons with type 2 diabetes [Abstract]

Broke-Smith, T. P., Luzio, Stephen Denis, Lockett, A., New, R. C. C. and Owens, David Raymond 2008. Repeat-dosing of oral insulin (Capsulin) in persons with type 2 diabetes [Abstract]. Diabetologia 51 (S1) , S8. 10.1007/s00125-008-1117-6

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Abstract

Background and aims: A 10 day repeat dose study to investigate twice-daily dosing with the oral insulin (CapsulinTM) in the treatment of type 2 diabetes. Materials and methods: 16 subjects (12 male) participated; mean (SD) age 60.2 (5.5) years, BMI 28.3 (3.4) kg/m2, HbA1c 7.5 (1.3) %. All subjects received 150U Capsulin BID given approximately one hour prior to breakfast and the evening meal for 10 consecutive days, during which self-monitored blood glucose (SMBG) readings were conducted 5-times a day (fasting, 2-hr after breakfast, before dinner, 2-hr after dinner, at bedtime). Prior to study entry, subjects were on stable doses of oral hypoglycaemic agents (OHA) for at least 3 months and had suboptimal glycaemic control. During the study, all OHAs apart from metformin were withdrawn (9 out of 16 subjects dropped at least one OHA; 14 remained on metformin; 2 were treated with Capsulin alone). Pre-study and post study screening occurred around 5 days prior and post the dosing period respectively. Results: During the repeat dosing period SMBG readings remained within the recommended range (6-11 mmol/L). Daily fluctuations in SMBG as assessed by the mean amplitude of glycaemic excursion (MAGE) analysis were reduced over the study period. Analysis of postprandial glucose (PPG) excursions indicated that by day 10 the proportion of post-meal values which fell within the ADA recommended range (<8.9 mmol/L) had increased from 9.7% (day 2) to 35.5% (day 10) (p=0.027). This effect was more pronounced during the evening meals where the proportion of data points that fell within the recommended range increased from 6.3% (day 2) to 43.8% (day 10) (p=0.009). These observations were associated with significant improvements in HbA1c (7.38±1.14% to 7.16±0.86%, p<0.05), weight (84.9±11.9 to 84.2±11.6kg, p<0.05) and triglycerides (1.83±0.88 to 1.53±0.60 mmol/l, p<0.05) between pre-study screen and study close. No serious adverse events and no hypoglycaemia were reported. Conclusion: The ability for Capsulin to potentially improve glycaemic control throughout the day (including mealtimes) without inducing hypoglycaemia may be due to its route of delivery via the hepatic portal system, thereby mimicking endogenous insulin secretion.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > RS Pharmacy and materia medica
Additional Information: Abstract Book 2008
Publisher: Springer
ISSN: 1432-0428
Last Modified: 15 Dec 2017 09:10
URI: http://orca.cf.ac.uk/id/eprint/17558

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