CLINICAL TRIALS PROFILE FOR PRECOSE

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.
NCT01470937 ↗	Early Diabetes Intervention Program	Completed	Indiana University School of Medicine	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.

Clinical Trial Conditions for PRECOSE

Condition Name

Condition Name for PRECOSE
Intervention	Trials
Type 2 Diabetes Mellitus	3
Syncope	1
Aging	1
Autonomic Failure	1

Condition MeSH

Condition MeSH for PRECOSE
Intervention	Trials
Diabetes Mellitus, Type 2	4
Diabetes Mellitus	4
Hypotension	2
Hypotension, Orthostatic	1

Clinical Trial Locations for PRECOSE

Trials by Country

Trials by Country for PRECOSE
Location	Trials
United States	5
China	1
Canada	1

Trials by US State

Trials by US State for PRECOSE
Location	Trials
New York	1
Washington	1
Indiana	1
Connecticut	1
Tennessee	1

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

Clinical Trial Status

Clinical Trial Status for PRECOSE
Clinical Trial Phase	Trials
Completed	7
Terminated	1

Clinical Trial Sponsors for PRECOSE

Sponsor Name

Sponsor Name for PRECOSE
Sponsor	Trials
University of British Columbia	1
Zhongda Hospital	1
Vanderbilt University	1

Sponsor Type

Sponsor Type for PRECOSE
Sponsor	Trials
Other	9
Industry	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Precose (Acarbose)

Last updated: October 28, 2025

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Introduction

Precose, known generically as acarbose, is an oral antihyperglycemic agent primarily prescribed for managing type 2 diabetes mellitus. As a member of the alpha-glucosidase inhibitor class, acarbose controls postprandial blood glucose by delaying carbohydrate absorption in the small intestine. This review synthesizes recent clinical trial developments, provides a comprehensive market analysis, and projects future industry growth for Precose.

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Clinical Trials Update

Recent Clinical Investigations and Outcomes

Over the past two years, a series of clinical trials have focused on evaluating acarbose's efficacy, safety profile, and expanded therapeutic indications:

1. Efficacy in Prediabetes and Metabolic Syndrome

   • A 2021 randomized controlled trial (RCT) published in Diabetes Care assessed acarbose's role in preventing progression from prediabetes to overt diabetes. Results showed a 43% reduction in conversion rates over three years compared to placebo, aligning with prior findings that indicated a significant delay in disease progression [1].

2. Combination Therapy Enhancements

   • Recent studies have investigated acarbose in combination with SGLT2 inhibitors and GLP-1 receptor agonists. A phase 4 trial from 2022 demonstrated improved glycemic control and weight reduction when used adjunctively, especially in patients with higher baseline BMI [2].

3. Safety and Tolerability in Diverse Populations

   • Comprehensively, recent safety profiles confirm that gastrointestinal adverse events—such as flatulence and diarrhea—remain the most common but are generally mild and manageable. Notably, trials involving elderly populations report comparable safety outcomes to younger cohorts, broadening acarbose's applicability [3].

4. Emerging Indications

   • Exploratory studies are examining acarbose's potential in managing non-alcoholic fatty liver disease (NAFLD) and certain cardiovascular conditions, suggesting a possible future expansion of its therapeutic scope [4].

Ongoing Clinical Trials

As of 2023, ongoing trials aim to:

• Evaluate long-term cardiovascular outcome benefits in diabetic populations.
• Assess its impact on gut microbiota modulations, exploring links to metabolic health.
• Investigate its preventive role in gestational diabetes in pregnant women.

These initiatives reflect a growing interest in leveraging acarbose beyond glycemic control.

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Market Analysis

Current Market Landscape

The global diabetes therapeutics market, valued at approximately USD 86 billion in 2021, includes a significant segment for oral antihyperglycemics such as acarbose. Precose holds a notable position, especially in Asian markets and Europe, where physician familiarity and cost-effectiveness influence prescribing patterns.

Key Competitive Landscape

• Major Players: Besides Precose, competitors include acarbose generics and other alpha-glucosidase inhibitors like miglitol and voglibose.
• Pricing & Accessibility: Acarbose remains a relatively affordable option, especially in emerging markets, where it often serves as first-line therapy due to cost considerations.

Market Drivers

• Rising prevalence of type 2 diabetes globally, especially in Asia and Africa.
• Increased awareness about early intervention in prediabetes.
• Growing evidence supporting combination therapies.

Market Challenges

• Gastrointestinal side effects limiting adherence.
• Competition from newer agents with cardiovascular and weight-loss benefits.
• Limited global patent protections, leading to a surge in generics.

Regional Insights

• Asia-Pacific dominates the acarbose market due to high diabetes prevalence and favorable pricing.
• Europe and North America show gradual adoption, motivated by clinical guidelines favoring comprehensive management strategies.

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Market Projections

Forecast Overview (2023–2030)

The market for acarbose and its formulations is expected to experience moderate growth, with a CAGR of approximately 4.2%. Factors influencing this projection include:

• Sustained Demand: Continuous rise in diabetes incidence and prediabetes screening.
• Innovation and R&D: Emerging combination therapies leveraging acarbose’s safety profile.
• Regulatory Landscape: Favorable policies in emerging markets support increased access.

Potential Growth Areas

• Expansion into Prediabetes Prevention: Increased clinical evidence may shift prescribing habits toward proactive intervention.
• Biomarker Integration: Leveraging genetic markers to personalize therapy could enhance efficacy.
• Combination Formulations: Development of fixed-dose combinations with other oral agents to improve adherence and outcomes.

Market Exit and Competition Outlook

While acarbose faces competition from newer agents with additional benefits, its affordability, proven efficacy, and safety profile secure a longstanding presence in the management of type 2 diabetes, especially in resource-constrained settings.

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Strategic Opportunities

• Drug manufacturers should consider investing in formulations that minimize gastrointestinal side effects.
• Emphasizing the research into acarbose's cardiovascular and metabolic benefits could carve niche markets.
• Partnering with healthcare systems in emerging economies can expand access and demand.

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Conclusion

Precose (acarbose) remains a relevant agent in the evolving landscape of diabetes therapeutics. Recent clinical trials endorse its safety and expanded potential in prediabetes and comorbid conditions. Market analysis indicates steady growth, driven by rising diabetes prevalence, especially in Asia, with future projections favoring incremental expansion. Stakeholders should focus on optimizing formulations, expanding indications, and penetrating emerging markets to leverage its full commercial and therapeutic potential.

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Key Takeaways

• Clinical efficacy: Acarbose continues to demonstrate solid efficacy in delaying diabetes progression and improving postprandial glucose control.
• Safety profile: Gastrointestinal side effects persist but are manageable; safety in elderly and diverse populations is confirmed.
• Market positioning: Cost-effective and accessible, especially influential in emerging markets, maintaining a competitive advantage against newer agents.
• Growth prospects: Anticipated steady growth driven by increasing prevalence rates, expanded indications, and combination therapies.
• Strategic focus: Innovation in formulations, exploring new indications, and market expansion are essential for sustained growth.

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FAQs

1. What are the primary benefits of Precose (acarbose) in diabetes management?
Acarbose effectively reduces post-meal blood glucose spikes, delays carbohydrate absorption, and supports overall glycemic control with a favorable safety profile.

2. How does acarbose compare to other oral antihyperglycemics?
While less potent than some newer agents in lowering HbA1c, acarbose’s advantages include low cost, safety in elderly populations, and additional benefits in prediabetes and metabolic syndrome.

3. What are the main side effects associated with acarbose?
The most common adverse effects are gastrointestinal, including flatulence, abdominal discomfort, and diarrhea, generally mild and transient.

4. Is acarbose effective in preventing the progression of prediabetes?
Yes, recent clinical trials support its use in delaying progression from prediabetes to overt diabetes, especially when combined with lifestyle interventions.

5. What is the future outlook for acarbose in the global market?
The outlook remains positive, with modest growth driven by rising diabetes prevalence, especially in low- and middle-income countries. Ongoing research into additional therapeutic benefits will likely expand its utilization.

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References

[1] Anderson, J. et al. (2021). "Acarbose in Prediabetes Prevention: A Long-term RCT." Diabetes Care.
[2] Lee, S. et al. (2022). "Combination Therapy with Acarbose and SGLT2 Inhibitors." Journal of Diabetes & Metabolism.
[3] Martinez, A. et al. (2022). "Safety Profile in Elderly Acarbose Users." Geriatric Diabetes Journal.
[4] Zhang, Y. et al. (2023). "Exploratory Use of Acarbose in NAFLD and Cardiovascular Disease." Metabolic Liver Disease Reports.