TY - JOUR
T1 - A placebo-controlled crossover study comparing the effects of nateglinide and glibenclamide on post prandial hyperglycaemia and hyperinsulaemia in patients with Type II diabetes
AU - Barnett, Anthony
AU - Anderson, DM
AU - Shelley, S
AU - Morgan, R
AU - Owens, DR
PY - 2004/1/1
Y1 - 2004/1/1
N2 - Aim: This was a randomized, double blind, three period crossover study. The objective was to compare glucose, insulin and C-peptide 24 h profiles in patients with type 2 diabetes mellitus after dosing with nateglinide (given preprandially before three test meals), glibenclamide (administered once before breakfast) or placebo (given before three test meals).
Methods: Fourteen patients underwent screening followed within 3 weeks by three treatment periods of 1 day, each separated by 7 days. Dosing followed a six-sequence balanced, two 3 x 3-replicated Latin square.
Results: Mean peak serum insulin levels were lower after nateglinide (115 mU/l) than after glibenclamide (145 mU/l.h; p = 0.017) but higher than after placebo (79 mU/l; p = 0.001). However, peak insulin levels were reached earlier after nateglinide [mean time to peak (t(max)) 1.7 h] compared to glibenclamide (mean t(max) 2.1 h, p = 0.06). Total insulin exposure over the day was higher after glibenclamide compared with that following nateglinide (1216 vs. 1067 mU/l.h; p = 0.009). Similar findings were seen with serum C-peptide. Despite this, mean peak plasma glucose concentrations were lower following nateglinide (11.4 mmol/l from a baseline of 8.3 mmol/l) compared with glibenclamide (13.2 mmol/l from a baseline of 8.5 mmol/l; p = 0.001) and placebo (14.0 mmol/l from a baseline of 8.0 mmol/L; p <0.001).
Conclusions: Nateglinide improves early prandial measures of insulin and glucose response to a standard meal, more so than glibenclamide, in people with type 2 diabetes.
AB - Aim: This was a randomized, double blind, three period crossover study. The objective was to compare glucose, insulin and C-peptide 24 h profiles in patients with type 2 diabetes mellitus after dosing with nateglinide (given preprandially before three test meals), glibenclamide (administered once before breakfast) or placebo (given before three test meals).
Methods: Fourteen patients underwent screening followed within 3 weeks by three treatment periods of 1 day, each separated by 7 days. Dosing followed a six-sequence balanced, two 3 x 3-replicated Latin square.
Results: Mean peak serum insulin levels were lower after nateglinide (115 mU/l) than after glibenclamide (145 mU/l.h; p = 0.017) but higher than after placebo (79 mU/l; p = 0.001). However, peak insulin levels were reached earlier after nateglinide [mean time to peak (t(max)) 1.7 h] compared to glibenclamide (mean t(max) 2.1 h, p = 0.06). Total insulin exposure over the day was higher after glibenclamide compared with that following nateglinide (1216 vs. 1067 mU/l.h; p = 0.009). Similar findings were seen with serum C-peptide. Despite this, mean peak plasma glucose concentrations were lower following nateglinide (11.4 mmol/l from a baseline of 8.3 mmol/l) compared with glibenclamide (13.2 mmol/l from a baseline of 8.5 mmol/l; p = 0.001) and placebo (14.0 mmol/l from a baseline of 8.0 mmol/L; p <0.001).
Conclusions: Nateglinide improves early prandial measures of insulin and glucose response to a standard meal, more so than glibenclamide, in people with type 2 diabetes.
KW - glibenclamide
KW - nateglinide
KW - pharmacodynamics
KW - pharmacokinetics
KW - type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=1242273649&partnerID=8YFLogxK
U2 - 10.1111/j.1462-8902.2004.00321.x
DO - 10.1111/j.1462-8902.2004.00321.x
M3 - Article
C2 - 14746575
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
SN - 1463-1326
VL - 6
SP - 104
EP - 113
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
ER -