|
 |
|
|||||||
|
|||||||||
© 2005 by the American Diabetes Association, Inc.
Clinical Care/Education/Nutrition |
PRESERVE-ß
Two-year efficacy and safety of initial combination therapy with nateglinide or glyburide plus metformin
1 General Clinical Research Center, University of Rochester, Rochester, New York
2 Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas
3 Clinical Development and Medical Affairs, Novartis Pharmaceuticals, East Hanover, New Jersey
4 Biometrics Medical Affairs, Novartis Pharmaceuticals, East Hanover, New Jersey
Address correspondence and reprint requests to Michelle A. Baron, MD, Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936. E-mail: michelle.baron{at}novartis.com
OBJECTIVE—To compare long-term efficacy and safety of initial combination therapy with nateglinide/metformin versus glyburide/metformin.
RESEARCH DESIGN AND METHODS—We conducted a randomized, multicenter, double-masked, 2-year study of 428 drug-naïve patients with type 2 diabetes. Patients received 120 mg a.c. nateglinide or 1.25 mg q.d. glyburide plus 500 mg q.d. open-label metformin for the initial 4 weeks. During a subsequent 12-week titration period, glyburide and metformin were increased by 1.25- and 500-mg increments to maximum daily doses of 10 and 2,000 mg, respectively, if biweekly fasting plasma glucose (FPG) 
6.7 mmol/l. Nateglinide was not titrated. Blinding was maintained by use of matching placebo for nateglinide and glyburide. An 88-week monitoring period followed, during which HbA1c (A1C), FPG, and postprandial glucose excursions (PPGEs) during an oral glucose tolerance test were measured.
RESULTS—In nateglinide/metformin-treated patients, mean A1C was 8.4% at baseline and 6.9% at week 104. In glyburide/metformin-treated patients, mean A1C was 8.3% at baseline and 6.8% at week 104 (P < 0.0001 vs. baseline for both treatments, NS between treatments). The 
PPGE averaged –96 ± 19 (P < 0.0001) and –57 ± 22 mmol · l–1 · min–1 (P < 0.05) in patients receiving nateglinide/metformin and glyburide/metformin, respectively, whereas FPG was –1.6 ± 0.2 (P < 0.0001) and –2.4 ± 0.2 mmol/l (P < 0.0001) in patients receiving nateglinide/metformin and glyburide/metformin, respectively (P < 0.01 between groups). Thus, the two treatments achieved similar efficacy with differential effects on FPG versus PPGE. Hypoglycemia occurred in 8.2 and 17.7% of patients receiving nateglinide/metformin and glyburide/metformin, respectively.
CONCLUSIONS—Similar good glycemic control can be maintained for 2 years with either treatment regimen, but nateglinide/metformin may represent a safer approach to initial combination therapy.
Abbreviations: AE, adverse event • FPG, fasting plasma glucose • ITT, intent to treat • PPGE, postprandial glucose excursion • SMBG, self-monitored blood glucose
CiteULike 
Del.icio.us 
Digg 
Reddit 
Technorati What's this?
This article has been cited by other articles:
|
|
 |
|
  M. J. Fowler Diabetes Treatment, Part 2: Oral Agents for Glycemic Management Clin. Diabetes, October 1, 2007; 25(4): 131 - 134. [Full Text] [PDF]
|
|
|
|
 |
|
 Z. T. Bloomgarden Exploring Treatment Strategies for Type 2 Diabetes Diabetes Care, October 1, 2007; 30(10): 2737 - 2745. [Full Text] [PDF]
|
|
|
|
|
|
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 | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| Diabetes | Diabetes Care | Clinical Diabetes | Diabetes Spectrum |