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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR TOLBUTAMIDE


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All Clinical Trials for Tolbutamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00082238 ↗ Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A 2003-03-01 People with CF have a high incidence of diabetes, called CFRD. CFRD is an important cause of worsened morbidity and mortality, thus understanding the pathophysiology underlying its development is imperative. Insulin deficiency has been well recognized as one cause of CFRD; however the clinical presentation and studies of pathogenesis indicate that the etiology is more complex. There is strong evidence that normal metabolism of carbohydrate, protein and fat is altered in CF. We believe that the inflammatory response to chronic underlying lung disease is responsible for insulin resistance and alters substrate metabolism, and that these changes, in addition to insulin deficiency cause CFRD. Our global hypothesis is that hyperglycemia is caused, in part, by high rates of gluconeogenesis resulting from excessive amino acid substrate availability caused by cytokine-mediated protein catabolism. We further hypothesize that inflammation alters normal fatty acid metabolism leading to lipogenesis, an energy wasteful pathway. We will recruit 24 adult CF subjects and 10 controls (similar in distribution in lean tissue mass, age and gender) and will categorize them according to glucose tolerance (OGTT), as well as insulin secretion and insulin sensitivity using the Tolbutamide-stimulated IVGTT and the Minimal Model. Clinical status will be characterized by measuring pulmonary function and modified NIH scores, in addition to measuring levels of circulating cytokines. Gluconeogenesis (GNG) will be quantified by measuring the incorporation 2H into the 2nd, 5th and 6th carbons of glucose. Amino acid turnover rates will be measured using stable isotopes of lactate and alanine and whole body protein turnover (WBPT) will be measured using [1-13C]leucine and [15N2]urea. Fat metabolism will be evaluated by measuring ketone body turnover using stable isotopes, and by quantifying lipogenesis using the isotopomer equilibration method. Key enzymes of fatty acid metabolism will also be measured. We will utilize indirect calorimetry to measure resting energy expenditure. Subjects will be recruited from the CF centers at the University of Texas- Southwestern and the South Central CF Consortium. Our proposal is intended to better describe the unique metabolism of people with CF, and to provide a comprehensive evaluation of pathophysiologic changes which contribute to the development of CFRD and to wasting; and are part of the applicant's long-range goal which is to identify the underlying causes of CF related diabetes and catabolism so that disease-specific therapies can be developed. We fully expect that the proposed studies will provide new and important information.
NCT00369304 ↗ Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2006-07-01 This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.
NCT00668395 ↗ Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics Completed Indiana University N/A 2007-05-01 1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your liver and thus speed up your liver's ability to get rid of efavirenz from your body. This may render efavirenz and other medications ineffective. 2. To see how efavirenz interact with other drugs taken at the same time with it. 3. To see if genetic differences can change the way how the liver breaks down efavirenz and its interactions with other co-administered drugs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tolbutamide

Condition Name

Condition Name for Tolbutamide
Intervention Trials
Healthy 6
Diabetes Mellitus, Type 2 3
Healthy Volunteers 2
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Condition MeSH

Condition MeSH for Tolbutamide
Intervention Trials
Diabetes Mellitus, Type 2 5
Diabetes Mellitus 5
Neoplasms 2
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Clinical Trial Locations for Tolbutamide

Trials by Country

Trials by Country for Tolbutamide
Location Trials
United States 22
United Kingdom 8
Canada 7
Netherlands 2
Germany 2
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Trials by US State

Trials by US State for Tolbutamide
Location Trials
Texas 3
Michigan 2
Arizona 2
California 2
Connecticut 1
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Clinical Trial Progress for Tolbutamide

Clinical Trial Phase

Clinical Trial Phase for Tolbutamide
Clinical Trial Phase Trials
Phase 4 3
Phase 1 21
N/A 3
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Clinical Trial Status

Clinical Trial Status for Tolbutamide
Clinical Trial Phase Trials
Completed 23
Terminated 3
Recruiting 1
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Clinical Trial Sponsors for Tolbutamide

Sponsor Name

Sponsor Name for Tolbutamide
Sponsor Trials
Canadian Institutes of Health Research (CIHR) 4
Drug Safety and Effectiveness Network, Canada 3
Canadian Network for Observational Drug Effect Studies, CNODES 3
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Sponsor Type

Sponsor Type for Tolbutamide
Sponsor Trials
Industry 20
Other 19
NIH 2
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Tolbutamide: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Tolbutamide, a first-generation sulfonylurea, has been a cornerstone in the treatment of type 2 diabetes mellitus for decades. Despite the emergence of newer antidiabetic drugs, tolbutamide remains relevant due to its efficacy and cost-effectiveness. Here, we delve into the current clinical trials, market analysis, and future projections for tolbutamide.

Historical Context and Mechanism of Action

Tolbutamide was one of the first oral hypoglycemic agents introduced in the 1950s. It works by stimulating the release of insulin from the pancreatic beta cells, thereby reducing blood glucose levels. This mechanism is particularly beneficial for patients with type 2 diabetes who have some residual insulin-producing capacity[4].

Clinical Trials and Efficacy

Historical clinical trials have provided valuable insights into the efficacy and limitations of tolbutamide. A study involving 1,030 diabetic patients highlighted that tolbutamide was most effective in patients whose diabetes onset occurred after the age of 40 and who required less than 20 units of insulin daily. However, primary and secondary failures were noted, with some patients experiencing unsatisfactory control over time[4].

Primary and Secondary Failure

Primary failure, where tolbutamide alone was inadequate from the outset, was observed in 136 patients. Secondary failure, where control became unsatisfactory after an initial period of good control, occurred in 40 patients. These findings underscore the need for continuous monitoring and potential adjustment of treatment regimens[4].

Market Analysis

The sulfonylureas market, which includes tolbutamide, is significant and continues to grow.

Market Size and Growth

As of 2024, the sulfonylureas market is estimated to be valued at USD 9.98 billion and is projected to reach USD 11.32 billion by 2029, growing at a CAGR of 3.12% during the forecast period. This growth is driven by the increasing prevalence of diabetes, particularly in regions like the Middle East and Africa[5].

Regional Market Dynamics

North America is the largest market for sulfonylureas, while the Middle East and Africa region is expected to witness the highest CAGR due to lifestyle changes and an alarming increase in diabetes prevalence. For instance, the IDF MENA Region had 73 million adults living with diabetes in 2021, a figure expected to rise to 95 million by 2030[5].

Key Players

The tolbutamide market includes several key players such as Pengyao Pharma, SINE, Changzhou Pharma, Changjiang Pharma, EASHU Pharma, Mylan, Sovereign, Vexxa LifeScience, and Genesis Pharma. These companies play a crucial role in manufacturing and distributing tolbutamide globally[2].

Market Drivers and Restraints

Market Drivers

  • Increasing Prevalence of Diabetes: The rising number of people with diabetes, especially in developing regions, drives the demand for oral antidiabetic drugs like tolbutamide.
  • Cost-Effectiveness: Tolbutamide is generally more affordable than newer antidiabetic medications, making it a preferred option in many healthcare systems.
  • COVID-19 Impact: The COVID-19 pandemic has highlighted the importance of effective glycemic control, further boosting the demand for sulfonylureas[5].

Market Restraints

  • Side Effects and Toxicity: Tolbutamide can cause side effects such as urticaria and minor digestive complaints, which can limit its use in some patients[4].
  • Emergence of Newer Therapies: The development of newer antidiabetic drugs with better safety profiles and efficacy, such as GLP-1 receptor agonists like tirzepatide, may reduce the market share of traditional sulfonylureas[1].

Future Projections

Despite the emergence of newer therapies, tolbutamide is expected to maintain its relevance due to its established efficacy and cost-effectiveness.

Continued Use in Developing Regions

In regions where access to healthcare is limited and newer drugs are less affordable, tolbutamide will likely remain a vital treatment option for type 2 diabetes.

Combination Therapies

Tolbutamide may be used in combination with other antidiabetic drugs to achieve better glycemic control. This approach can enhance its efficacy and extend its utility in clinical practice.

Key Takeaways

  • Efficacy and Limitations: Tolbutamide is effective in certain patient populations but can experience primary and secondary failures.
  • Market Growth: The sulfonylureas market, including tolbutamide, is expected to grow at a CAGR of 3.12% from 2024 to 2029.
  • Regional Dynamics: The Middle East and Africa region will see the highest growth due to increasing diabetes prevalence.
  • Cost-Effectiveness: Tolbutamide remains a cost-effective option, especially in developing regions.
  • Future Relevance: Despite newer therapies, tolbutamide will continue to be used, particularly in combination with other antidiabetic drugs.

FAQs

What is the primary mechanism of action of tolbutamide?

Tolbutamide works by stimulating the release of insulin from the pancreatic beta cells, thereby reducing blood glucose levels.

Which regions are expected to see the highest growth in the sulfonylureas market?

The Middle East and Africa region is expected to witness the highest CAGR due to lifestyle changes and an alarming increase in diabetes prevalence.

What are the common side effects associated with tolbutamide?

Common side effects include urticaria and minor digestive complaints.

How does the COVID-19 pandemic impact the sulfonylureas market?

The COVID-19 pandemic has highlighted the importance of effective glycemic control, further boosting the demand for sulfonylureas.

What are the key players in the tolbutamide market?

Key players include Pengyao Pharma, SINE, Changzhou Pharma, Changjiang Pharma, EASHU Pharma, Mylan, Sovereign, Vexxa LifeScience, and Genesis Pharma.

Sources

  1. SURPASS-5 Randomized Clinical Trial - PubMed
  2. Global Tolbutamide Market Research Report 2024 - Valuates Reports
  3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - Biospace
  4. RESULTS OF LONG-TERM USE OF TOLBUTAMIDE (ORINASE) IN ... - JAMA Network
  5. Sulfonylureas Market - Share, Size & Growth - Mordor Intelligence

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