Abstract | 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 HbA(1c) >7 and < or =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 HbA(1c) 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: 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 HbA(1c) and FPG values after 16 weeks of therapy.
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Authors | Julio Rosenstock, David R Hassman, Robert D Madder, Shari A Brazinsky, James Farrell, Naum Khutoryansky, Paula M Hale, Repaglinide Versus Nateglinide Comparison Study Group |
Journal | Diabetes care
(Diabetes Care)
Vol. 27
Issue 6
Pg. 1265-70
(Jun 2004)
ISSN: 0149-5992 [Print] United States |
PMID | 15161773
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biomarkers
- Carbamates
- Cyclohexanes
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Piperidines
- Nateglinide
- Phenylalanine
- repaglinide
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Topics |
- Biomarkers
(blood)
- Body Mass Index
- Carbamates
(therapeutic use)
- Cyclohexanes
(therapeutic use)
- Diabetes Mellitus, Type 2
(diet therapy, drug therapy, rehabilitation)
- Diet, Diabetic
- Exercise
- Female
- Glycated Hemoglobin
(analysis)
- Humans
- Hypoglycemic Agents
(therapeutic use)
- Male
- Middle Aged
- Nateglinide
- Phenylalanine
(analogs & derivatives, therapeutic use)
- Piperidines
(therapeutic use)
- Time Factors
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