Diabetes Care
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow Request Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Rosenstock, J.
Right arrow Articles by Hale, P. M.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Rosenstock, J.
Right arrow Articles by Hale, P. M.
Social Bookmarking
Add to CiteULike   Add to Del.icio.us   Add to Digg   Add to Reddit   Add to Technorati  
What's this?
Diabetes Care 27:1265-1270, 2004
© 2004 by the American Diabetes Association, Inc.

Clinical Care/Education/Nutrition
Original Article

Repaglinide Versus Nateglinide Monotherapy

A randomized, multicenter study

Julio Rosenstock, MD1, David R. Hassman, DO2, Robert D. Madder, DO3, Shari A. Brazinsky, MD4, James Farrell, MD5, Naum Khutoryansky, PHD6 and Paula M. Hale, MD6 for the Repaglinide Versus Nateglinide Comparison Study Group*

1 Dallas Diabetes and Endocrine Center, Dallas, Texas
2 Comprehensive Clinical Research, Berlin, New Jersey
3 Tri-State Medical Group, Beaver, Pennsylvania
4 Institute of Health Care Assessment, San Diego, California
5 Midwest Pharmaceutical Research, St. Peters, Missouri
6 Novo Nordisk Pharmaceuticals, Princeton, New Jersey

Address correspondence and reprint requests to Dr. Julio Rosenstock, Dallas Diabetes and Endocrine Center, 7777 Forest Ln., Suite C618, Dallas, TX 75230. E-mail: juliorosenstock{at}dallasdiabetes.com

OBJECTIVE—A randomized, parallel-group, open-label, multicenter 16-week clinical trial compared efficacy and safety of repaglinide monotherapy and nateglinide monotherapy in type 2 diabetic patients previously treated with diet and exercise.

RESEARCH DESIGN AND METHODS—Enrolled patients (n = 150) had received treatment with diet and exercise in the previous 3 months with HbA1c >7 and <=12%. Patients were randomized to receive monotherapy with repaglinide (n = 76) (0.5 mg/meal, maximum dose 4 mg/meal) or nateglinide (n = 74) (60 mg/meal, maximum dose 120 mg/meal) for 16 weeks. Primary and secondary efficacy end points were changes in HbA1c and fasting plasma glucose (FPG) values from baseline, respectively. Postprandial glucose, insulin, and glucagon were assessed after a liquid test meal (baseline, week 16). Safety was assessed by incidence of adverse events or hypoglycemia.

RESULTS—Mean baseline HbA1c values were similar in both groups (8.9%). Final HbA1c values were lower for repaglinide monotherapy than nateglinide monotherapy (7.3 vs. 7.9%). Mean final reductions of HbA1c were significantly greater for repaglinide monotherapy than nateglinide monotherapy (–1.57 vs. –1.04%; P = 0.002). Mean changes in FPG also demonstrated significantly greater efficacy for repaglinide than nateglinide (–57 vs. –18 mg/dl; P < 0.001). HbA1c values <7% were achieved by 54% of repaglinide-treated patients versus 42% for nateglinide. Median final doses were 6.0 mg/day for repaglinide and 360 mg/day for nateglinide. There were 7% of subjects treated with repaglinide (five subjects with one episode each) who had minor hypoglycemic episodes (blood glucose <50 mg/dl) versus 0 patients for nateglinide. Mean weight gain at the end of the study was 1.8 kg in the repaglinide group as compared with 0.7 kg for the nateglinide group.

CONCLUSIONS—In patients previously treated with diet and exercise, repaglinide and nateglinide had similar postprandial glycemic effects, but repaglinide monotherapy was significantly more effective than nateglinide monotherapy in reducing HbA1c and FPG values after 16 weeks of therapy.

Abbreviations: AUC, area under the curve • FPG, fasting plasma glucose • IMI, incremental mean imputation • LOCF, last observation carried forward • SMBG, self-monitoring of blood glucose


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


This article has been cited by other articles:


Home page
 Diabetes Spectr.Home page
P. Hollander
Anti-Diabetes and Anti-Obesity Medications: Effects on Weight in People With Diabetes
Diabetes Spectr, July 1, 2007; 20(3): 159 - 165.
[Abstract] [Full Text] [PDF]

Home page
 Diabetes CareHome page
D. M. Nathan, J. B. Buse, M. B. Davidson, R. J. Heine, R. R. Holman, R. Sherwin, and B. Zinman
Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes
Diabetes Care, August 1, 2006; 29(8): 1963 - 1972.
[Full Text] [PDF]

Home page
 The Diabetes EducatorHome page
D. F. Kruger, C. L. Martin, and C. E. Sadler
New insights into glucose regulation.
The Diabetes Educator, March 1, 2006; 32(2): 221 - 228.
[Abstract] [Full Text] [PDF]

Home page
 Diabetes CareHome page
N. N. Zammitt and B. M. Frier
Hypoglycemia in Type 2 Diabetes: Pathophysiology, frequency, and effects of different treatment modalities
Diabetes Care, December 1, 2005; 28(12): 2948 - 2961.
[Full Text] [PDF]

Home page
 The Annals of PharmacotherapyHome page
M. Malone
Medications Associated with Weight Gain
Ann. Pharmacother., December 1, 2005; 39(12): 2046 - 2054.
[Abstract] [Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Diabetes Diabetes Care Clinical Diabetes Diabetes Spectrum
Copyright © 2004 by the American Diabetes Association.