HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Fonseca, V. Articles by Foley, J. E. Search for Related Content PubMed PubMed Citation Articles by Fonseca, V. Articles by Foley, J. E. Social Bookmarking                What's this?

Addition of Nateglinide to Rosiglitazone Monotherapy Suppresses Mealtime Hyperglycemia and Improves Overall Glycemic Control

¹ Tulane University Medical Center, New Orleans, Louisiana
² Grunberger Diabetes Institute, Bloomfield Hills, Michigan
³ Novartis Pharmaceuticals, East Hanover, New Jersey

OBJECTIVE—To determine the effects of nateglinide added to rosiglitazone monotherapy on glycemic control and on postprandial glucose and insulin levels in patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS—This 24-week, multicenter, double-blind, randomized study compared the efficacy of nateglinide (120 mg a.c.) and placebo added to rosiglitazone monotherapy (8 mg q.d.) in 402 patients with type 2 diabetes with HbA_1c between 7 and 11% (inclusive). Efficacy parameters tested included HbA_1c and plasma glucose and insulin levels in the fasting state and after a standardized meal challenge. Safety data were also collected.

RESULTS—In placebo-treated patients, HbA_1c did not change ( = 0.0 ± 0.1%). In patients randomized to nateglinide, HbA_1c decreased from 8.3 to 7.5% ( = -0.8 ± 0.1%, P < 0.0001 vs. placebo). Target HbA_1c (<7.0%) was achieved by 38% of patients treated with combination therapy and by 9% of patients remaining on rosiglitazone monotherapy. In nateglinide-treated patients, fasting plasma glucose levels decreased by 0.7 mmol/l, 2-h postprandial glucose levels decreased by 2.7 mmol/l, and 30-min insulin levels increased by 165 pmol/l compared with no changes from baseline of these parameters with placebo added to rosiglitazone (P < 0.001).

CONCLUSIONS—By selectively augmenting early insulin release and decreasing prandial glucose excursions, nateglinide produced a clinically meaningful improvement in overall glycemic exposure in patients with type 2 diabetes inadequately controlled with rosiglitazone. Therefore, nateglinide substantially improves the likelihood of achieving a therapeutic target of HbA_1c <7.0%.

Abbreviations: AE, adverse event • AUC, area under the curve • CHF, congestive heart failure • FPG, fasting plasma glucose • HOMA, homeostasis model assessment • ITT, intent to treat • PPG, postprandial glucose • SAE, serious adverse event • TZD, thiazolidinedione

CiteULike    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				B. Kimmel and S. E. Inzucchi Oral Agents for Type 2 Diabetes: An Update Clin. Diabetes, April 1, 2005; 23(2): 64 - 76. [Abstract] [Full Text] [PDF]