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Last Updated: April 25, 2025

CLINICAL TRIALS PROFILE FOR PRECOSE


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All Clinical Trials for Precose

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00223691 ↗ Treatment of Orthostatic Hypotension in Autonomic Failure Completed Vanderbilt University Phase 1 2002-03-01 The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00223691 ↗ Treatment of Orthostatic Hypotension in Autonomic Failure Completed Vanderbilt University Medical Center Phase 1 2002-03-01 The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00846521 ↗ Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity Terminated National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 4 2006-09-01 The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.
NCT00846521 ↗ Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity Terminated Yale University Phase 4 2006-09-01 The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.
NCT01177384 ↗ Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130) Completed Merck Sharp & Dohme Corp. Phase 3 2011-01-25 This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C) more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM with inadequate glycemic control on acarbose monotherapy.
NCT01470937 ↗ Early Diabetes Intervention Program Completed Bayer Phase 4 1998-02-01 This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Precose

Condition Name

Condition Name for Precose
Intervention Trials
Type 2 Diabetes Mellitus 3
Aging 1
Autonomic Failure 1
Cardiovascular Disease 1
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Condition MeSH

Condition MeSH for Precose
Intervention Trials
Diabetes Mellitus, Type 2 4
Diabetes Mellitus 4
Hypotension 2
Syncope 1
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Clinical Trial Locations for Precose

Trials by Country

Trials by Country for Precose
Location Trials
United States 5
China 1
Canada 1
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Trials by US State

Trials by US State for Precose
Location Trials
New York 1
Washington 1
Indiana 1
Connecticut 1
Tennessee 1
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Clinical Trial Progress for Precose

Clinical Trial Phase

Clinical Trial Phase for Precose
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Precose
Clinical Trial Phase Trials
Completed 7
Terminated 1
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Clinical Trial Sponsors for Precose

Sponsor Name

Sponsor Name for Precose
Sponsor Trials
Yale University 1
Merck Sharp & Dohme Corp. 1
Bayer 1
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Sponsor Type

Sponsor Type for Precose
Sponsor Trials
Other 9
Industry 2
NIH 1
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Clinical Trials, Market Analysis, and Projections for PRECOSE and Related Therapeutic Areas

Introduction

PRECOSE, a drug used to manage type 2 diabetes, is part of a broader landscape of clinical trials and market dynamics. This article will delve into the current state of clinical trials, particularly focusing on personalized and omics-based approaches, and provide a market analysis and projection for the therapeutic areas related to PRECOSE.

Personalized Clinical Trials: The PRECISE Study Example

The Personalized Immunomodulation in Pediatric Sepsis-Induced MODS Trial (PRECISE), though not directly related to PRECOSE, exemplifies the trend towards personalized medicine in clinical trials. This study, funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, aims to improve outcomes in children with sepsis-induced multi-organ dysfunction syndrome (MODS) by tailoring treatments based on immune function phenotyping[1].

  • GRACE-2 and TRIPS Trials: These sub-trials within PRECISE use different interventions (GM-CSF and anakinra) based on the patient's immune response profile, highlighting the importance of personalized treatment strategies.
  • Observational Cohort: This aspect of the study collects data from patients who do not qualify for the intervention arms, providing valuable real-world data.

Omics-Based Clinical Trials

Omics-based clinical trials, which include genomics, proteomics, and metabolomics, are becoming increasingly significant. These trials offer a more precise approach to drug development and patient treatment.

  • Market Size and Growth: The global omics-based clinical trials market is projected to grow from USD 32.85 billion in 2024 to USD 70.92 billion by 2034, at a CAGR of 8.0%[3].
  • Key Drivers: The growth is driven by increasing investments by pharmaceutical companies, the rising demand for personalized medicine, and technological advancements in high-throughput screening and next-generation sequencing.
  • Regional Dominance: North America currently dominates the omics-based clinical trials market, but the Asia Pacific region is also seeing significant growth due to its diverse patient population and advancements in clinical research.

Market Analysis for Diabetes Management

The market for diabetes management, where PRECOSE is positioned, is influenced by several factors:

  • Personalized Medicine: The trend towards personalized medicine is expected to impact diabetes treatment. Omics-based trials can help in identifying genetic markers and metabolic profiles that can tailor treatments to individual patients, potentially improving the efficacy and safety of drugs like PRECOSE[3].
  • Technological Advancements: Advances in data analytics and genomics are enabling better patient stratification and more accurate dosing, which can enhance the market for drugs targeting specific patient populations.
  • Regulatory Support: Regulatory bodies are increasingly supportive of integrating omics data into clinical trial research, which can accelerate the development and approval of new and improved diabetes treatments.

Projections for the Diabetes Management Market

  • Growth Potential: The diabetes management market, including drugs like PRECOSE, is expected to grow significantly due to the increasing prevalence of diabetes and the demand for more effective and personalized treatments.
  • Competitive Landscape: The market is highly competitive, with several pharmaceutical companies investing in research and development to create more targeted and effective therapies. The integration of omics technologies is likely to further differentiate products and drive market growth.
  • Emerging Markets: Regions like the Asia Pacific are expected to contribute significantly to the growth of the diabetes management market due to their large and diverse patient populations and growing healthcare infrastructure[3].

Impact of Economic and Market Outlook

The broader economic and market outlook can influence the pharmaceutical industry, including the market for diabetes management drugs.

  • Global Economic Trends: The global economy is expected to face various challenges in 2025, including trade-policy uncertainty and tariffs, which could impact the pharmaceutical sector. However, regions like the U.S. are projected to achieve a soft landing with steady economic growth[5].
  • Investment and Innovation: Despite economic uncertainties, technological innovation, particularly in AI and data analytics, is expected to continue driving growth in the pharmaceutical sector. This innovation can enhance the development and marketing of drugs like PRECOSE[2].

Key Takeaways

  • Personalized Medicine: Clinical trials are increasingly adopting personalized approaches, which can improve treatment outcomes and are likely to influence the development and marketing of drugs like PRECOSE.
  • Omics-Based Trials: The growth of omics-based clinical trials is driven by technological advancements and regulatory support, and these trials are expected to play a crucial role in the future of diabetes management.
  • Market Growth: The diabetes management market is projected to grow significantly, driven by the increasing prevalence of diabetes and the demand for more effective and personalized treatments.
  • Economic and Market Outlook: The global economic trends and technological innovations will continue to shape the pharmaceutical industry, including the market for diabetes management drugs.

FAQs

  1. What is the significance of personalized medicine in clinical trials? Personalized medicine in clinical trials involves tailoring treatments based on individual patient profiles, such as genetic or immune response data, to improve treatment outcomes and reduce adverse effects.

  2. How is the omics-based clinical trials market expected to grow? The omics-based clinical trials market is projected to grow from USD 32.85 billion in 2024 to USD 70.92 billion by 2034, at a CAGR of 8.0%, driven by technological advancements and increasing demand for personalized medicine.

  3. What role does regulatory support play in omics-based clinical trials? Regulatory bodies are increasingly supportive of integrating omics data into clinical trial research, which helps in improving drug efficacy and safety and accelerates the development and approval of new treatments.

  4. How does the economic outlook impact the pharmaceutical industry? The economic outlook, including factors like trade-policy uncertainty and tariffs, can impact the pharmaceutical sector. However, regions with steady economic growth, like the U.S., are expected to continue driving innovation and investment in the industry.

  5. What are the key drivers of growth in the diabetes management market? The key drivers include the increasing prevalence of diabetes, the demand for personalized and effective treatments, and technological advancements in genomics and data analytics.

Sources

  1. CPCCRN - PRECISE Study https://www.cpccrn.org/precise-study/

  2. J.P. Morgan Research - Market Outlook 2025 https://www.jpmorgan.com/insights/global-research/outlook/market-outlook

  3. Biospace - Omics-based Clinical Trials Market Size https://www.biospace.com/press-releases/omics-based-clinical-trials-market-size-to-hit-usd-70-92-billion-by-2034

  4. JAMA Cardiology - PRECISE Trial https://jamanetwork.com/journals/jamacardiology/fullarticle/2808765

  5. Russell Investments - 2025 Annual Global Market Outlook https://russellinvestments.com/us/blog/2025-annual-global-market-outlook

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