A placebo-controlled crossover study comparing the effects of nateglinide and glibenclamide on post prandial hyperglycaemia and hyperinsulaemia in patients with Type II diabetes

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@article{82067de2651141e89d419838506584b7,
title = "A placebo-controlled crossover study comparing the effects of nateglinide and glibenclamide on post prandial hyperglycaemia and hyperinsulaemia in patients with Type II diabetes",
abstract = "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.",
keywords = "glibenclamide, nateglinide, pharmacodynamics, pharmacokinetics, type 2 diabetes",
author = "Anthony Barnett and DM Anderson and S Shelley and R Morgan and DR Owens",
year = "2004",
month = jan,
day = "1",
doi = "10.1111/j.1462-8902.2004.00321.x",
language = "English",
volume = "6",
pages = "104--113",
journal = "Diabetes, obesity & metabolism",
issn = "1462-8902",
publisher = "Wiley",

}

RIS

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

VL - 6

SP - 104

EP - 113

JO - Diabetes, obesity & metabolism

JF - Diabetes, obesity & metabolism

SN - 1462-8902

ER -