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Last Updated: April 2, 2025

CLINICAL TRIALS PROFILE FOR NATEGLINIDE


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All Clinical Trials for NATEGLINIDE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00238472 ↗ A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion Completed Novartis Pharmaceuticals Phase 4 2003-05-01 This study is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.
NCT00212290 ↗ Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 4 2002-11-01 The purpose of this study is to examine the effects of treating insulin resistance on memory and attention, brain glucose utilization, and proteins in spinal fluid.
NCT00097786 ↗ Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications Completed Novartis Pharmaceuticals Phase 3 2002-01-01 This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.
NCT00189774 ↗ Nateglinide: a Double Blind Add-on Study With Pioglitazone for Type 2 Diabetic Patients Completed Ajinomoto USA, INC. Phase 2/Phase 3 1969-12-31 The purpose of this study is to investigate the superiority of nateglinide over placebo for inadequately controlled type 2 diabetic patients with pioglitazone treatment.
NCT00189774 ↗ Nateglinide: a Double Blind Add-on Study With Pioglitazone for Type 2 Diabetic Patients Completed Astellas Pharma Inc Phase 2/Phase 3 1969-12-31 The purpose of this study is to investigate the superiority of nateglinide over placebo for inadequately controlled type 2 diabetic patients with pioglitazone treatment.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for NATEGLINIDE

Condition Name

7632001234567Type 2 Diabetes MellitusDiabetes Mellitus, Type 2Type 2 DiabetesDiabetes Mellitus[disabled in preview]
Condition Name for NATEGLINIDE
Intervention Trials
Type 2 Diabetes Mellitus 7
Diabetes Mellitus, Type 2 6
Type 2 Diabetes 3
Diabetes Mellitus 2
[disabled in preview] 0
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Condition MeSH

171520024681012141618Diabetes MellitusDiabetes Mellitus, Type 2Insulin ResistanceGlucose Intolerance[disabled in preview]
Condition MeSH for NATEGLINIDE
Intervention Trials
Diabetes Mellitus 17
Diabetes Mellitus, Type 2 15
Insulin Resistance 2
Glucose Intolerance 1
[disabled in preview] 0
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Clinical Trial Locations for NATEGLINIDE

Trials by Country

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Trials by Country for NATEGLINIDE
Location Trials
United States 5
Korea, Republic of 5
Japan 5
Canada 3
China 3
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Trials by US State

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Trials by US State for NATEGLINIDE
Location Trials
New York 1
Georgia 1
Florida 1
New Jersey 1
Washington 1
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Clinical Trial Progress for NATEGLINIDE

Clinical Trial Phase

66.7%14.3%14.3%002468101214Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for NATEGLINIDE
Clinical Trial Phase Trials
Phase 4 14
Phase 3 3
Phase 2/Phase 3 1
[disabled in preview] 3
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Clinical Trial Status

91.7%0-2024681012141618202224CompletedRecruitingTerminated[disabled in preview]
Clinical Trial Status for NATEGLINIDE
Clinical Trial Phase Trials
Completed 22
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for NATEGLINIDE

Sponsor Name

trials011223344556Novartis PharmaceuticalsCanadian Institutes of Health Research (CIHR)Drug Safety and Effectiveness Network, Canada[disabled in preview]
Sponsor Name for NATEGLINIDE
Sponsor Trials
Novartis Pharmaceuticals 5
Canadian Institutes of Health Research (CIHR) 3
Drug Safety and Effectiveness Network, Canada 3
[disabled in preview] 5
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Sponsor Type

66.7%31.4%005101520253035OtherIndustryNIH[disabled in preview]
Sponsor Type for NATEGLINIDE
Sponsor Trials
Other 34
Industry 16
NIH 1
[disabled in preview] 0
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Nateglinide: Clinical Trials, Market Analysis, and Projections

Introduction to Nateglinide

Nateglinide is an oral antidiabetic drug used in the management of type 2 diabetes. It belongs to the meglitinide class, which works by stimulating the pancreas to release insulin, thereby reducing blood glucose levels. Here, we will delve into the clinical trials, market analysis, and future projections for nateglinide.

Clinical Trials and Efficacy

Monotherapy and Combination Therapy

Clinical trials have extensively evaluated the efficacy and safety of nateglinide in both monotherapy and combination therapy settings. A notable study compared nateglinide with repaglinide, another meglitinide analog, in patients with type 2 diabetes who had been treated with diet and exercise for the previous 3 months. This 16-week trial showed that nateglinide, administered at doses of 60 mg to 120 mg before meals, resulted in significant reductions in HbA1c levels, although repaglinide was found to be more effective in this particular study (mean HbA1c reduction of 1.04% for nateglinide vs. 1.57% for repaglinide)[1].

In another study, nateglinide was evaluated in combination with metformin. This 24-week trial demonstrated that the combination of nateglinide and metformin was effective in reducing HbA1c levels, with nateglinide showing a favorable pharmacodynamic profile compared to other antidiabetic medications[4].

Safety and Tolerability

Clinical trials have generally shown that nateglinide is well-tolerated. Common adverse effects include gastrointestinal distress and mild symptoms suggestive of hypoglycemia, such as increased sweating, dizziness, and tremor. However, clinically significant changes in liver function tests have not been reported during nateglinide therapy[4].

Market Analysis

Current Market Size and Growth

The global nateglinide market was valued at USD 538.23 million in 2022. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 10.4% from 2023 to 2030, reaching an estimated value of USD 1,187.74 million by 2030[3].

Market Segmentation

The nateglinide market is segmented based on therapy type (monotherapy and combination therapy), indication (diabetes, obesity, others), end-users (hospitals, homecare, specialty clinics, others), and distribution channels (hospital pharmacy, online pharmacy, retail pharmacy). Monotherapy is expected to dominate the therapy segment due to increasing investments in healthcare[3].

Regional Insights

North America is anticipated to dominate the market due to factors such as rising healthcare costs, increased research and development, and technological advancements. Other key regions include Europe, Asia-Pacific, and the Middle East and Africa, with countries like the U.S., Canada, Germany, France, China, Japan, and India playing significant roles[3][5].

Market Drivers and Opportunities

Increasing Diabetes Prevalence

The rising global burden of type 2 diabetes is a major driver for the nateglinide market. As the diabetic population grows, so does the demand for effective oral antidiabetic drugs like nateglinide[3].

Technological Advancements

Advances in pharmaceutical research and development have led to the introduction of more efficient and targeted antidiabetic medications. These advancements continue to positively impact the nateglinide market[3].

Increasing Diabetes Awareness

Growing emphasis on preventive healthcare and increasing awareness about diabetes present opportunities for educating people about early diagnosis and effective management, which can lead to an increased demand for antidiabetic medications like nateglinide[3].

Market Challenges and Restraints

Competition from Other Antidiabetic Drugs

The antidiabetic drug market is highly competitive, with various classes of drugs available, including biguanides (e.g., metformin), thiazolidinediones (e.g., pioglitazone), and DPP-4 inhibitors. This competition can pose a challenge to the growth of the nateglinide market[4].

Adverse Effects and Hypoglycemia Risk

While nateglinide is generally well-tolerated, its potential to cause mild hypoglycemia and gastrointestinal distress can be a restraint, especially in patients who are sensitive to these side effects[4].

Future Projections

Market Forecast

The global nateglinide market is expected to experience significant growth driven by the increasing prevalence of diabetes and advancements in pharmaceutical technology. By 2030, the market is projected to reach USD 1,187.74 million, with a CAGR of 10.4% during the forecast period[3].

Key Players and Competition

Major players in the nateglinide market include Novartis and CTTQ PHARMA, among others. These companies are expected to continue investing in research and development to enhance their market positions and respond to the growing demand for antidiabetic medications[5].

Key Takeaways

  • Efficacy and Safety: Nateglinide has been shown to be effective in reducing HbA1c levels in clinical trials, both as monotherapy and in combination with other antidiabetic drugs.
  • Market Growth: The global nateglinide market is projected to grow significantly, driven by the increasing prevalence of type 2 diabetes and technological advancements.
  • Market Segmentation: The market is segmented by therapy type, indication, end-users, and distribution channels, with monotherapy expected to dominate.
  • Regional Insights: North America is expected to dominate the market, followed by other key regions like Europe and Asia-Pacific.
  • Drivers and Opportunities: Increasing diabetes prevalence and technological advancements are key drivers, while growing awareness about diabetes presents opportunities.

FAQs

What is nateglinide used for?

Nateglinide is used in the management of type 2 diabetes to stimulate the pancreas to release insulin, thereby reducing blood glucose levels.

How effective is nateglinide compared to other antidiabetic drugs?

Clinical trials have shown that nateglinide is effective in reducing HbA1c levels, although its efficacy can vary compared to other drugs like repaglinide. For example, repaglinide was found to be more effective in one comparative study[1].

What are the common side effects of nateglinide?

Common side effects include gastrointestinal distress and mild symptoms suggestive of hypoglycemia, such as increased sweating, dizziness, and tremor[4].

What is the projected market size of nateglinide by 2030?

The global nateglinide market is projected to reach USD 1,187.74 million by 2030, growing at a CAGR of 10.4% from 2023 to 2030[3].

Which regions are expected to dominate the nateglinide market?

North America is expected to dominate the market, followed by Europe, Asia-Pacific, and the Middle East and Africa[3][5].

Sources

  1. Repaglinide Versus Nateglinide Monotherapy | Diabetes Care - Clinical trials comparing repaglinide and nateglinide.
  2. Global Nateglinide Market Analysis, Demand & Growth Forecast - Market segmentation and growth forecast.
  3. Nateglinide Market Size, Outlook & Growth Forecast Report By 2030 - Market size, CAGR, and regional insights.
  4. Emerging Drug List - NATEGLINIDE - Clinical trials, efficacy, and safety profile.
  5. Nateglinide Global Market Size, Competitors & Forecast - Market forecast, key players, and regional analysis.

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