Repaglinide Versus Nateglinide Monotherapy
Open accessAbstract
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.
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In insulin or insulin secretagogue users, PA can complicate diabetes management because they frequently have the effects of both exercise and insulin to increase glucose uptake.
“In insulin or insulin secretagogue users, who frequently have the effects of both exercise and insulin to increase glucose uptake, PA can complicate diabetes management ( 138 , 198 , 230 , 293 ).”
From Exercise and Type 2 Diabetes (2010) · cites this paper as [230]
The paper’s introductory section says repaglinide and nateglinide stimulate insulin release, and its Safety section discusses possible hypoglycemic events with improved glycemic control. It does not examine whether physical activity and insulin have combined effects on glucose uptake or whether physical activity complicates management for insulin or secretagogue users. (LLM, conf=0.85)
Experimental — accuracy not yet measuredMedication adjustments for PA are generally necessary only with use of insulin and other insulin secretagogues.
“Medication adjustments for PA are generally necessary only with use of insulin and other insulin secretagogues ( 161 , 230 ).”
From Exercise and Type 2 Diabetes (2010) · cites this paper as [230]
The Research Design and Methods section describes dose adjustments based on glucose readings, while the Safety section discusses hypoglycemia with two insulin secretagogues. Neither addresses medication adjustments for physical activity or compares which drug classes require them (searched: physical activity, exercise, medication adjustment). Page numbers were not available in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredNateglinide is somewhat less effective in lowering A1C than repaglinide when used as monotherapy or in combination therapy.
“Nateglinide is somewhat less effective in lowering A1C than repaglinide when used as monotherapy or in combination therapy (57,58).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [57]
In a randomized multicenter trial comparing repaglinide with nateglinide, slightly lower A1C values were achieved after 16 weeks on repaglinide, but 7% of patients had experienced mild hypoglycemia compared with none in the nateglinide group.
“In a randomized multicenter trial comparing repaglinide with nateglinide, slightly lower A1C values were achieved after 16 weeks on repaglinide, but 7% of patients had experienced mild hypoglycemia compared with none in the nateglinide group (128).”
From Hypoglycemia in Type 2 Diabetes (2005) · cites this paper as [128]
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References 15 · Cited by 180
Research works printed but not linked: 1
- [15]15. Khutoryansky NM, Huang WC: Imputa- tion techniques using SAS software for in- complete data in diabetes clinical trials. In Pharmaceutical Industry SAS Users Group Conference Proceedings, Boston, MA, 20 -23 May 2001. p. 334 -337
- Authors
- Rosenstock, J., Hassman, D. R., Madder, R. D., Brazinsky, S. A., Farrell, J., Khutoryansky, N., Hale, P. M., & for the Repaglinide Versus Nateglinide Comparison Study Group
- Affiliations
- Dallas Diabetes and Endocrine Center, Dallas, Texas
- Comprehensive Clinical Research (US)
- Tri-State Medical Group, Beaver, Pennsylvania
- Institute of Health Care Assessment, San Diego, California
- Midwest Pharmaceutical Research, St. Peters, Missouri
- Novo Nordisk Pharmaceuticals, Princeton, New Jersey
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2004-06-01
- Volume
- 27
- Issue
- 6
- Pages
- 1265-1270
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2113396466
- Cited by
- 180
- References
- 15
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 2 · 2022: 3 · 2021: 3 · 2020: 3 · 2019: 6 · 2018: 4 · 2017: 5 · 2016: 10 · 2015: 10 · 2014: 4 · 2013: 12 · 2012: 10
- FWCI
- 7.43
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Novo Nordisk
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- repaglinide, nateglinide, type 2 diabetes, monotherapy, glycemic control, HbA1c, fasting blood glucose, postprandial blood glucose, hypoglycemia, weight gain, sulfonylureas, diet and exercise, adverse events, drug safety and efficacy comparison, glycemic variability
- MeSH terms
- Nateglinide, Carbamates, Cyclohexanes, Diabetes Mellitus, Type 2, Diet, Diabetic, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Phenylalanine, Piperidines, Time Factors, Biomarkers, Exercise, Body Mass Index
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