Vol 5, No 5 (2004): Practical Diabetology
Original articles (translated)
Published online: 2004-10-26
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Repaglinide versus nateglinide monotherapy. A randomized, multicenter study

Julio Rosenstock, David R. Hassman, Robert D. Madder, Shari A. Brazinsky, James Farrell, Naum Khutoryansky, Paula M. Hale, członkowie zespołu Repaglinide Versus Na Group
Diabetologia Praktyczna 2004;5(5):261-270.
Vol 5, No 5 (2004): Practical Diabetology
Original articles (translated)
Published online: 2004-10-26

Abstract

INTRODUCTION. A randomized, parallel-group, openlabel, 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.
MATERIAL 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.

Abstract

INTRODUCTION. A randomized, parallel-group, openlabel, 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.
MATERIAL 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.
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Keywords

type 2 diabetes; repaglinide; nateglinide; monotherapy

About this article
Title

Repaglinide versus nateglinide monotherapy. A randomized, multicenter study

Journal

Clinical Diabetology

Issue

Vol 5, No 5 (2004): Practical Diabetology

Pages

261-270

Published online

2004-10-26

Bibliographic record

Diabetologia Praktyczna 2004;5(5):261-270.

Keywords

type 2 diabetes
repaglinide
nateglinide
monotherapy

Authors

Julio Rosenstock
David R. Hassman
Robert D. Madder
Shari A. Brazinsky
James Farrell
Naum Khutoryansky
Paula M. Hale
członkowie zespołu Repaglinide Versus Na Group

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