Author Affiliations
Abstract
Nateglinide is a non-sulfonylurea insulin designed for the treatment of type 2 diabetes. It activates pancreatic beta cells to produce insulin in response to meals by minimizing postprandial blood glucose levels. Clinical investigations performed between 2000 and 2024 demonstrated that nateglinide effectively reduces blood glucose levels. When used with other antidiabetic medicines, it enhances glycemic control in T2DM patients.
It promotes insulin release by inhibiting ATP-sensitive potassium channels in pancreatic beta cells, which results in the opening of calcium channels and ultimately insulin production. Nateglinide has a quick onset and short duration of effect for controlling postprandial glucose levels.
Because of its quick start of action, nateglinide has a lower risk of hypoglycemia when compared to other insulin medications like sulfonylureas. Nateglinide has also been linked to minimal weight gain due to its positive effects on insulin sensitivity. To improve glycemic control, it is used in conjunction with other antidiabetic medications.
Keywords
Insulin resistance, Liver, Muscle, Type 2 diabetes mellitus, β-cell, Glycemic control.
Introduction
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder that arises due to insulin resistance and impaired insulin secretion, resulting in persistent hyperglycemia. The increasing prevalence of T2DM globally is a major public health concern with various complications, including cardiovascular disease, neuropathy, nephropathy, and retinopathy.[1]
Effective management of blood glucose levels is critical to preventing or delaying these complications. Over the years, various pharmacological agents have been developed to improve glycemic control in T2DM patients. The safety profile of nateglinide is generally favorable, with a lower risk of hypoglycemia compared to traditional sulfonylureas. This is attributed to its rapid action and short half-life, which limit the duration of insulin secretion following meals. Weight gain, a common side effect associated with insulin secretagogues, is minimal with nateglinide, making it an attractive option for patients concerned about weight management.[2]
Nateglinide is a rapid-acting insulin secretagogue, has emerged as an important therapeutic option, particularly for controlling postprandial glucose excursions. Numerous clinical trials and studies have assessed the efficacy of nateglinide in managing blood glucose levels in patients with T2DM. Nateglinide has been shown to effectively reduce postprandial hyperglycemia, a key contributor to elevated HbA1c levels. When used as monotherapy, nateglinide can lower HbA1c by approximately 0.5-1%, a reduction comparable to that achieved with other oral antidiabetic agents.[3]
Nateglinide belongs to the meglitinide class of drugs, which are non-sulfonylurea insulin secretagogues. Nateglinide is a D-phenylalanine derivative, distinct from sulfonylureas, and exerts its effects by binding to the sulfonylurea receptor on pancreatic beta cells.[4]
This binding action closes ATP-sensitive potassium channels, causing membrane depolarization and the subsequent opening of voltage-dependent calcium channels.[5] The influx of calcium ions triggers the exocytosis of insulin-containing granules, thus stimulating insulin secretion. A key feature of nateglinide is its rapid onset and short duration of action, particularly effective at mimicking the early-phase insulin release that is typically deficient in T2DM. Following oral administration, nateglinide is rapidly absorbed, with peak plasma concentrations occurring within 1 hour, and it has a half-life of approximately 1.5 hours. This pharmacokinetic profile aligns well with its primary role in controlling postprandial glucose levels, without significantly increasing the risk of late postprandial hypoglycemia, a common concern with long-acting secretagogues.[6]
Methodology
To evaluate nateglinide’s safety and efficacy for the management of type 2 diabetes mellitus, this study combines a systematic review and meta-analysis. The main objective is to obtain information about the effects of nateglinide on postprandial glucose levels, glycemic control, and safety profile through observational studies, clinical trials, and other relevant studies.
Data Extraction:
To evaluate the effectiveness and safety of nateglinide in the treatment of Type 2 diabetes mellitus (T2DM) between 2000 to 2024, a systematic evaluation of observational studies and clinical trials was conducted. Using the search phrases nateglinide, Type 2 diabetes mellitus, postprandial glucose, meglitinide, and insulin secretion, the data was taken from the PubMed database. Only English-language research papers were included in the search. The data collection procedure for the extraction process encompassed gathering information about the study’s design, demographic characteristics, treatment duration, glycemic control outcomes, and adverse events.
HbA1c and postprandial glucose variations were the main outcomes of interest. Changes in weight, incidence of hypoglycemia, fasting plasma glucose, and other safety-related occurrences were indicators of secondary outcomes. The 95% confidence intervals and the mean difference, as well as the risk ratio for each study, were computed or extracted.
Inclusion Criteria:
Studies investigated the effects of nateglinide as monotherapy or in combination with other antidiabetic agents.
Studies reporting on at least one of the following outcomes: HbA1c levels, fasting plasma glucose, postprandial glucose, early-phase insulin secretion, or adverse events.
Articles published between January 2000 and September 2024. Only English-language articles were considered. Randomized controlled trials (RCTs), observational studies, and meta-analyses were included.
Population considered for this study including adults (≥18 years) diagnosed with T2DM or impaired glucose tolerance.
Exclusion Criteria:
Preclinical studies or studies conducted on animals were excluded. Studies that did not report relevant outcomes or lacked sufficient data for analysis.
Studies with a duration of less than 12 weeks were excluded unless they provided significant insights into the pharmacodynamics or pharmacokinetics of nateglinide.
Studies published in languages other than English were excluded.
Studies that did not report relevant glycemic outcomes or safety data, or those focusing only on mechanistic aspects without clinical relevance.
Case reports, reviews, editorials, and non-peer-reviewed articles were excluded. Additionally, studies with small sample sizes (<10 participants) or short follow-up periods (<4 weeks) were excluded.
Data Analysis:
Data from the selected studies were synthesized to evaluate the overall efficacy of nateglinide in managing T2DM. The primary outcome measure was to reduce HbA1c levels, while secondary outcomes were to change fasting plasma glucose, postprandial glucose levels, and the incidence of adverse events.
The quality of included studies was assessed using the Cochrane Risk of Bias tool for RCTs and the Newcastle-Ottawa Scale for observational studies. Studies were graded as high, moderate, or low quality based on these assessments. Only studies with moderate to high quality were included in the final analysis to ensure the reliability of the conclusions.
Results
Data were extracted on study design, sample size, intervention details, outcomes related to diabetes, and statistical values.
Plasma Glucose and Glycated Insulin:
Lindsay et al. (2003) aimed to evaluate the impact of nateglinide on glycated insulin levels and glucose tolerance.[7]
Nateglinide treatment reduced plasma glucose levels by 9% (P=0.005) and glycated insulin levels by 38% (P=0.047) compared to placebo.
Insulin and C-Peptide Levels:
The area under the curve (AUC) for insulin was enhanced by 36% (P=0.005) and for C-peptide by 25% (P=0.007) with nateglinide.
Interpretation:
Nateglinide was effective in lowering glycated insulin levels, indicating a reduction in the release of insulin with impaired bioactivity. This reduction likely contributes to improved glucose tolerance as observed with an increased release of native insulin and improved glycemic control. Thus, nateglinide’s mechanism of action involves enhancing the release of functional insulin and reducing the impact of glycated insulin, which may help in managing type 2 diabetes more effectively.
Postprandial Glucose Levels:
Bellomo et al. (2011) compared the efficacy of nateglinide and glyburide in managing postprandial glucose levels.[8]
When compared to glyburide, nateglinide substantially decreased the 2-hour postprandial glucose excursions (-2.4 vs. -1.6 mmol/L; P=0.02). Additionally, it showed a greater reduction in glucose excursions after a meal after one hour (-1.7 vs. -0.9 mmol/L; P=0.016).
Glycemic Control:
The study demonstrated that although glyburide’s once-daily regimen was less effective, nateglinide’s higher-frequency dosing, which matched mealtime intake, resulted in more effective handling of postprandial hyperglycemia.
Interpretation:
When compared to glyburide, nateglinide offered better control over postprandial glucose excursions. Furthermore, it was linked with a reduced rate of hypoglycemia, which is noteworthy considering that glyburide may result in hypoglycemic episodes. According to these results, patients with type 2 diabetes may find that nateglinide is a more secure and effective option for controlling postprandial hyperglycemia.
Postprandial Glycemia:
Tentolouris et al. (2005) examined the effects of a single dose of nateglinide on various metabolic and coagulation parameters in type 2 diabetes.[9]
Nateglinide significantly reduced postprandial glycemia compared to placebo (P<0.001).
Plasma insulin levels were significantly higher after nateglinide administration than after placebo (P=0.002).
Coagulation and Fibrinolysis:
Nateglinide resulted in a lower overall postprandial reduction of tissue-plasminogen activator compared to placebo (-2.9 ± 1.3 vs. -8.3 ± 3.7 ng/ml h; P=0.003).
There was a significant reduction in postprandial plasminogen activator inhibitor-1 compared to baseline values after nateglinide (P=0.001), but the overall difference between nateglinide and placebo was not significant (P=0.31).
Plasma concentrations of C-peptide, lipids, and other coagulation parameters did not differ significantly between nateglinide and placebo.
Interpretation:
Acute administration of nateglinide effectively improves postprandial glycemia and has a positive impact on fibrinolytic activity. The observed reduction in postprandial tissue-plasminogen activator and reduction in plasminogen activator inhibitor-1 suggest potential benefits in terms of reducing cardiovascular risk, in addition to improving glycemic control. These effects if sustained over a longer period then it may potentially contribute to reduced cardiovascular risk in patients with type 2 diabetes.
Postprandial Glucose Excursions:
Juurinen et al. (2009) the author evaluated the effects of adding nateglinide or placebo to basal insulin and metformin on postprandial glucose excursions (PPGEs), glycated hemoglobin (HbA1c), and hypoglycemia.[10]
Mean postprandial glucose levels over weeks 20 to 24 were much lower in the nateglinide group (9.0 ± 0.3 mmol/L) compared to the placebo group (10.0 ± 0.3 mmol/L; P = 0.025).
The mean PPGE was also lower in the nateglinide group (2.4 ± 0.2 mmol/L) compared to the placebo group (3.1 ± 0.2 mmol/L; P = 0.019).
HbA1c decreased by 0.41 ± 0.12% in the nateglinide group compared to a decrease of 0.04 ± 0.12% in the placebo group (P = 0.023).
Hypoglycemia:
The frequency of confirmed symptomatic hypoglycemia was higher in the nateglinide group (7.7 episodes/patient-year) compared to the placebo group (4.7 episodes/patient-year; P = 0.031).
Interpretation:
Adding nateglinide to basal insulin and metformin significantly improved postprandial glucose control and reduced HbA1c compared to placebo, indicating better glycemic management. This benefit came with an increased risk of hypoglycemia. The findings suggest that while nateglinide is effective in reducing postprandial hyperglycemia, careful management is required to mitigate the increased risk of hypoglycemic events.
Fasting Plasma Glucose:
Ristic et al. (2007), the researchers compared the long-term efficacy and safety of nateglinide plus metformin versus gliclazide plus metformin in patients with type 2 diabetes who were inadequately controlled with metformin monotherapy.[11]
No significant difference in fasting plasma glucose change was observed between the groups (nateglinide: -0.2 mmol/l vs. gliclazide: -0.7 mmol/l; P = 0.096).
HbA1c:
No significant difference in HbA1c reduction was observed between the two groups after 52 weeks:
Nateglinide group: -0.14%
Gliclazide group: -0.27%
Similar proportions of patients in both groups achieved an HbA1c of <7% (nateglinide: 40% vs. gliclazide: 47.4%).
Prandial Plasma Glucose:
The prandial plasma glucose area under the curve (AUC 0-4 h) decreased significantly in the nateglinide group (-3.26 h × mmol/l; P = 0.006), but not in the gliclazide group (-1.86 h × mmol/l).
Insulin Response:
Nateglinide treatment augmented the initial insulin response to a meal, while no significant between-treatment difference was noted in the 2-h insulin response.
Hypoglycemia and Weight Gain:
The overall rate of hypoglycemic events was similar between both groups.
Nateglinide plus metformin treatment was not associated with weight gain, unlike some traditional sulfonylureas.
Interpretation:
Both nateglinide plus metformin and gliclazide plus metformin combinations demonstrated similar efficacy in HbA1c reduction over 52 weeks. However, nateglinide had a more favourable effect on prandial plasma glucose and initial insulin response without causing weight gain, making it a potential alternative for patients concerned with postprandial glucose control and weight management.
| Aspect | Details |
| Drug Class | Non-sulfonylurea insulin secretagogue |
| Mechanism of Action | Stimulates pancreatic beta cells to release insulin in response to meals |
| Onset of Action | Rapid (within 30 minutes) |
| Duration of Action | Short (approximately 2-4 hours) |
| Primary Use | Control of postprandial hyperglycemia |
| Efficacy | Effective in lowering postprandial blood glucose levels and improving overall glycemic control |
| Combination Therapy | Can be used alone or in combination with other antidiabetic agents (e.g., metformin) |
| Benefits | Relatively low risk of hypoglycemia compared to sulfonylureas; may contribute to weight management |
| Common Side Effects | Hypoglycemia, gastrointestinal symptoms, potential weight gain |
| Long-Term Effects | Generally well-tolerated; long-term efficacy and safety continue to be evaluated in ongoing studies |
| Patient Population | Suitable for patients with postprandial hyperglycemia and those needing additional glycemic control |
| Dosing | Typically taken before meals; dose adjustments based on individual patient response |
| Contraindications | Not recommended in patients with type 1 diabetes or diabetic ketoacidosis |
| Recent Studies | Show continued effectiveness in managing postprandial glucose with a good safety profile |
Table 1: The role of nateglinide in the management of type 2 diabetes mellitus
Discussion
Mechanism and Effectiveness:
Nateglinide is a member of the meglitinide class of medications that works primarily as a postprandial glucose regulator. Its rapid onset and short duration of action make it particularly effective at controlling blood glucose spikes following meals. This targeted approach helps manage postprandial hyperglycemia, which is crucial for overall glycemic control in T2DM patients. Studies have consistently demonstrated that lowers postprandial glucose levels effectively, thereby contributing to improved HbA1c levels when used alone or in combination with other antidiabetic agents.[12]
Advantages Over Other Antidiabetics:
One of the notable advantages of nateglinide compared to traditional sulfonylureas is its lower risk of hypoglycemia. This reduced risk is attributed to its short action duration, which limits prolonged insulin secretion. Their effect on postprandial glucose control can be beneficial for patients who experience significant glucose spikes after meals but have relatively stable fasting glucose levels.[13]
Combination Therapy and Flexibility:
Nateglinide can be used alone or in conjunction with other diabetes medications such as metformin or thiazolidinediones. This flexibility allows for available treatment plans that address both fasting and postprandial glucose control. For many patients, this combination approach can lead to better overall glycemic management and reduced risk of long-term diabetes-related complications.[14]
Safety and Tolerability:
In terms of safety, nateglinide is generally well-tolerated. The risk of hypoglycemia is lower compared to other insulin drugs. Hence, it is a better option for patients who are at risk for or concerned about hypoglycemic episodes.[15]
Monitoring and management of these side effects are important to maintain patient adherence and overall treatment success.[16]
Long-Term Considerations:
Long-term studies continue to support the efficacy of nateglinide in managing postprandial glucose levels, although further research is necessary to fully understand its impact on long-term glycemic control and cardiovascular outcomes.[17] The medication’s role in weight management and its potential benefits for patients with a propensity for weight gain are also areas of ongoing research.[18]
Patient-Specific Factors:
Individual patient characteristics such as baseline glucose levels, coexisting health conditions, and concurrent medications can influence the effectiveness of nateglinide. Personalizing treatment based on these factors is crucial to achieving optimal glycemic control and minimizing adverse effects.[19]
Limitations and Future Directions for Research
Limitations:
Limited Long-Term Data: While nateglinide has demonstrated short-term efficacy in controlling postprandial glucose levels, there is a relative scarcity of long-term data on its impact on overall glycemic control, cardiovascular outcomes, and diabetes-related complications.[20]
Potential for Weight Gain: It is likely to cause hypoglycemia, but nateglinide can still lead to weight gain in some patients. The long-term implications of this effect on metabolic health and diabetes management require further investigation.[21]
Patient-Specific Variability: The effectiveness of nateglinide can vary significantly among individuals based on factors such as baseline glucose levels, concurrent medications, and overall health status. This variability highlights the need for more personalized treatment approaches and may limit the ability of study findings.[22]
Comparative Effectiveness: Nateglinide is effective for postprandial glucose control. Its direct comparisons with other antidiabetic agents (e.g., SGLT2 inhibitors, GLP-1 receptor agonists) are needed to assess its relative benefits and drawbacks in various patient populations.[23]
Adverse Effects: While generally well-tolerated, nateglinide can cause gastrointestinal disturbances and other side effects. A comprehensive understanding of its safety profile, including rare but serious adverse effects, is necessary for informed clinical decision-making.[24]
Future Directions for Research:
Long-Term Outcomes: Research should focus on long-term studies to evaluate nateglinide’s impact on overall glycemic control, cardiovascular health, and the prevention of diabetes-related complications. This includes assessing its effects on mortality and quality of life.[25]
Mechanistic Studies: The exact mechanisms need to be known for further studies by which nateglinide affects glucose metabolism and insulin secretion. This can help identify which patients might benefit from its use.[26]
Comparative Effectiveness: Comparative studies with other antidiabetic agents are essential to determine nateglinide’s relative efficacy and safety. This includes head-to-head trials with other drugs and combination therapies to establish optimal treatment strategies.[27]
Personalized Medicine: Research should explore how individual patient characteristics influence the response to nateglinide. This will help treatments to individual needs and improve overall treatment outcomes.[28]
Impact on Weight Management: Investigations into the effects of nateglinide on weight and metabolic health are needed. Understanding the conditions under which nateglinide may contribute to weight gain can help develop strategies to mitigate this effect.[29]
Real-World Evidence: Collect data from real-world clinical settings can provide insights into the practical challenges of using nateglinide including, patient adherence, effectiveness, and safety in diverse populations.[30]
Conclusion
Nateglinide is a therapeutic option in the management of type 2 diabetes mellitus (T2DM) for addressing postprandial hyperglycemia. Its rapid onset and short duration of action are well-suited for controlling glucose spikes following meals to improve overall glycemic control. Lower risk of drug-induced hypoglycemia compared to sulfonylureas, and its effectiveness in combination with other antidiabetic agents adds to its clinical value.
While nateglinide is generally well-tolerated and offers advantages in managing postprandial glucose, careful consideration of patient-specific factors is essential for maximum benefits. Ongoing research will continue to clarify its long-term efficacy and safety, particularly in body weight and cardiovascular outcomes.
Personalized treatment strategies based on individual patient needs and responses are crucial in optimizing the use of nateglinide and achieving the best possible outcomes in T2DM management.
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Acknowledgments
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Author Information
Corresponding Author:
Shubham Ravindra Sali
Independent Researcher, Department of Content
medtigo India Pvt Ltd, Pune, India
Email: shubhamsali42@gmail.com
Co-Authors:
Mansi Srivastava
Independent Researcher, Department of Content
medtigo India Pvt Ltd, Pune, India
Email: srivastavamansi811@gmail.com
Samatha Ampeti
Department of Pharmacology
Kakatiya University, University College of Pharmaceutical Sciences, Warangal, TS, India
Email: ampetisamatha9@gmail.com
Raziya Begum Sheikh
Independent Researcher, Department of Content
medtigo India Pvt Ltd, Pune, India
Email: raziya.pharma@gmail.com
Sonam Shashikala B V
Independent Researcher, Department of Content
medtigo India Pvt Ltd, Pune, India
Email: venkateshsonams@gmail.com
Authors Contributions
All authors contributed to the conceptualization, investigation, and data curation by acquiring and critically reviewing the selected articles. They were collectively involved in the writing – original draft preparation, and writing – review & editing to refine the manuscript. Additionally, all authors participated in the supervision of the work, ensuring accuracy and completeness. The final manuscript was approved by all named authors for submission to the journal.
Informed Consent
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DOI
Cite this Article
Shubham RS, Mansi S, Samatha A, Raziya BS, Sonam SBV. A Review on Impact of Nateglinide on Postprandial Glycemia, Insulin Secretion, and Cardiovascular Risk in Type 2 Diabetes Mellitus. medtigo J Pharmacol. 2024;1(1):e3061115. doi:10.63096/medtigo3061115 Crossref
