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The NEPI Antidiabetes Study (NANSY). 1: Short‐term dose–effect relations of glimepiride in subjects with impaired fasting glucose *
Author(s) -
Lindblad U.,
Lindwall K.,
Sjöstrand Å.,
Ranstam J.,
Melander And A.
Publication year - 2001
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1046/j.1463-1326.2001.00166.x
Subject(s) - glimepiride , medicine , placebo , type 2 diabetes , confidence interval , impaired fasting glucose , diabetes mellitus , endocrinology , hypoglycemia , gastroenterology , impaired glucose tolerance , alternative medicine , pathology
SUMMARYAim NANSY is a randomised, placebo‐controlled Swedish‐Norwegian study which aims to include 2 × 1112 male and female subjects with impaired fasting glucose (IFG), to assess whether conversion to type 2 diabetes can be delayed by addition of sulphonylurea to dietary regulation and increased exercise. This pilot study was conducted to find the optimum dose of glimepiride in NANSY. Methods In a double blind trial in primary care 25 IFG subjects were in random order exposed to single doses and one‐week treatments with 0 (placebo), 0.5, 1.0 and 2.0 mg glimepiride once daily. The optimum dose was assessed by measuring blood glucose during oral 75 g glucose tolerance test (OGTT), comparing fasting blood glucose, and the area under the blood glucose curve (AUC), and by monitoring hypoglycaemic events. Results With single doses, there was a clear dose–response relationship for the reduction in AUC, with a statistically significant difference only between placebo (mean 1981, 95% confidence intervals (CI) 1883–2078) and 2 mg glimepiride (mean 1763, 95% CI 1665–1861). However, following 1‐week treatments, the only significant difference was between placebo (mean 1934, 95% CI 1856–2012) and 1 mg glimepiride (mean 1714, 95% CI 1637–1792). Correspondingly, the only statistically significant difference in fasting blood glucose day 7 was between placebo (5.87 mmol/l, 95% CI 5.68–6.05 mmol/l) and 1 mg glimepiride (5.42 mmol/l, 95% CI 5.21–5.62 mmol/l). Chemical hypoglycaemia was common but hypoglycaemic symptoms were rare and similar between the active doses, and easily countered by the subjects. Conclusions The sulphonylurea dose–effect curve may be bell‐shaped, perhaps due to down regulation of sulphonylurea receptors during chronic exposure. Alternatively, the finding could be a rebound phenomenon, secondary to preceding hypoglycaemia. The optimum dose for NANSY was found to be 1 mg glimepiride.