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Management of Type 2 Diabetes Mellitus

Defining the Role of Nateglinide

  • Drugs in Disease Management
  • Published:
Disease Management & Health Outcomes

Abstract

Type 2 diabetes mellitus is a progressive disease with an insidious onset. It is thought to affect up to 10% of European and North American populations with a significantly higher incidence in non-White than in White populations. Complications of the disease are associated with considerable morbidity and mortality and their management consumes significant healthcare resources.

Data from the United Kingdom Prospective Diabetes Study have shown that intensive glycemic control reduces the microvascular complications of type 2 disease and that intensive management of fasting plasma glucose (FPG) levels is insufficient over time to provide such control. Recent studies have demonstrated that lowering postprandial plasma (PPG) glucose levels provides some additional glycemic control and recent epidemiologic data suggest reducing PPG levels may be associated with a reduction in mortality.

In patients with type 2 diabetes mellitus inadequately controlled by diet and exercise, nateglinide significantly improved glycemic control compared with placebo; a beneficial effect on both FPG and PPG levels was observed. In active comparator studies, nateglinide has been shown to be as effective as metformin (in pharmacotherapy-naïve patients), acarbose and troglitazone in reducing glycosylated hemoglobin (HbA1c) levels.

When used in combination with metformin (in patients inadequately controlled on maximum dosages of metformin monotherapy) nateglinide significantly improves glycemic control compared with placebo. In addition, nateglinide has been shown to display pronounced additive effects when added to troglitazone or metformin in patients inadequately controlled by diet and exercise alone.

Nateglinide was generally well tolerated in clinical trials. The most common adverse event was hypoglycemia, although the incidence was low in comparison with sulfonylureas. The incidence of hypoglycemia was increased in patients using nateglinide in combination with metformin.

By controlling HbA1c and PPG, nateglinide has the potential to provide substantial health and quality-of-life benefits; however, long-term outcome data and validated quality-of-life assessments are lacking. In economic modelling studies, the estimated cost-effectiveness ratios observed with nateglinide were well within the range for therapies considered to be cost-effective.

In conclusion, nateglinide is a useful addition to the available treatments for type 2 diabetes mellitus. It significantly improved glycemic control in pharmacotherapy-naïve patients as well as in patients not adequately controlled by metformin alone; however, until long-term clinical data become available, nateglinide can only be considered as an adjunct to metformin in patients inadequately controlled on metformin alone in whom PPG levels are elevated. Nateglinide is well tolerated and has low potential to cause hypoglycemia and bodyweight gain.

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  1. Adis International Inc., 860 Town Center Drive, Langhorne, Pennsylvania, 19047, USA

    Christopher I. Carswell, Christine R. Culy & Caroline M. Perry

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  1. Christopher I. Carswell
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Correspondence to Christopher I. Carswell.

Additional information

Various sections of the manuscript reviewed by: J. Gleeson, Lovelace Health Systems, Albuquerque, New Mexico, USA; V. Grill, Department of Internal Medicine, University Hospital of Trondheim, Trondheim, Norway; C. Heller, Athena Healthcare Communications Inv, Chicago, Illinois, USA; D. Huse, Policy Analysis Inc, Brookline, Massachusetts, USA; D.W. Plocher, Minneapolis Health Care Consulting, Ernst & Young LLP, Minneapolis, Michigan, USA; D.C. Suh, College of Pharmacy, Rutgers -The State University of New Jersey, Piscataway, New Jersey, USA; J.R. White, Department of Pharmacotherapy, Washington State University, Spokane, Washington, USA.

Data Selection

Sources: Medical literature published in any language since 1980 on nateglinide, identified using Medline, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: Medline search terms were ‘diabetes mellitus type 2 ’ or ‘diabetes mellitus non-insulin-dependent’ and (‘guidelines’ or ‘decision-making’ or ‘health-policy’ or ‘managed-care-programs’ or ‘epidemiology’ or ‘outcome-assessment-health-care’ or ‘clinical-protocols’ or ‘guideline in pt’ or ‘polic* in ti’ or ‘expert panel’ or ‘utilization review’ or ‘algorithms’ or ‘disease management’ or ‘quality of life’), or ‘nateglinide’ and ‘review in pt’. AdisBase search terms were ‘type-2-diabetes-mellitus’ and (‘guideline’ or ‘guideline-utilization’ or ‘practice-guideline’ or ‘disease-management-programs’ or ‘treatment-algorithms’ or ‘reviews-on-treatment’ or ‘drug-evaluations’ or ‘epidemiology’ or ‘cost-of-illness’ or ‘pathogenesis’), or ‘nateglinide’ and (‘review’ or ‘clinical-study’). Searches were last updated 14th April 2001.

Selection: Studies in patients with type 2 diabetes mellitus who received nateglinide. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic, pharmacokinetic, pharmacoeconomic and epidemiological data are also included.

Index terms: Nateglinide, diabetes mellitus, disease management, review on treatment.

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Carswell, C.I., Culy, C.R. & Perry, C.M. Management of Type 2 Diabetes Mellitus. Dis-Manage-Health-Outcomes 10, 363–383 (2002). https://doi.org/10.2165/00115677-200210060-00006

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