CLINICAL TRIALS PROFILE FOR ACARBOSE

All Clinical Trials for Acarbose

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	Centers for Disease Control and Prevention	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Eye Institute (NEI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute on Aging (NIA)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	National Eye Institute (NEI)	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	SmithKline Beecham	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.

Clinical Trial Conditions for Acarbose

Condition Name

Condition Name for Acarbose
Intervention	Trials
Type 2 Diabetes Mellitus	23
Diabetes Mellitus, Type 2	14
Diabetes Mellitus	10
Type 2 Diabetes	9

Condition MeSH

Condition MeSH for Acarbose
Intervention	Trials
Diabetes Mellitus	58
Diabetes Mellitus, Type 2	53
Glucose Intolerance	7
Syndrome	5

Clinical Trial Locations for Acarbose

Trials by Country

Trials by Country for Acarbose
Location	Trials
China	94
United States	44
Canada	9
Korea, Republic of	8
Spain	7

Trials by US State

Trials by US State for Acarbose
Location	Trials
Washington	5
Texas	3
Tennessee	3
New York	3
Minnesota	3

Clinical Trial Progress for Acarbose

Clinical Trial Phase

Clinical Trial Phase for Acarbose
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	20
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Acarbose
Clinical Trial Phase	Trials
Completed	55
Unknown status	18
Recruiting	6

Clinical Trial Sponsors for Acarbose

Sponsor Name

Sponsor Name for Acarbose
Sponsor	Trials
Bayer	13
Canadian Institutes of Health Research (CIHR)	4
Sanofi	4

Sponsor Type

Sponsor Type for Acarbose
Sponsor	Trials
Other	89
Industry	45
NIH	6

Acarbose: Clinical Trials, Market Analysis, and Projections

Introduction to Acarbose

Acarbose is an alpha-glucosidase inhibitor that delays the absorption of carbohydrates in the intestines, making it a valuable treatment for type 2 diabetes mellitus. Here, we will delve into the latest clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Current Clinical Trials

A recent study is investigating the safety and tolerability of acarbose in combination with immunotherapy-based standard of care therapy in patients with advanced renal cell carcinoma (RCC). This trial aims to determine the feasibility of using acarbose in a new therapeutic context, beyond its traditional use in diabetes management[1].

Glycemic Control and Cardiovascular Benefits

Acarbose has been extensively studied for its efficacy in glycemic control. A randomized double-blind trial involving 1,946 patients with type 2 diabetes showed that acarbose significantly improved glycemic control over a 3-year period, regardless of the concomitant diabetes therapy. The study found a 0.2% lower median HbA1c in patients treated with acarbose compared to those on placebo[4].

Additionally, meta-analyses have highlighted the cardiovascular benefits of acarbose. It has been shown to reduce the risk of myocardial infarction by 64% and any cardiovascular event by 35% in patients with type 2 diabetes. These findings suggest that acarbose could be an alternative first-line oral therapy for type 2 diabetes, especially for its cardio-protective effects[3].

Side Effects and Compliance

While acarbose is effective, it is not without side effects. The most common reasons for noncompliance are flatulence and diarrhea. Despite these side effects, careful titration of the drug can help manage these issues and improve patient compliance[4].

Market Analysis

North America Alpha-Glucosidase Inhibitors Market

The North America alpha-glucosidase inhibitors market, which includes acarbose, is estimated to be USD 0.28 billion in 2024 and is projected to grow to USD 0.32 billion by 2029, with a Compound Annual Growth Rate (CAGR) of 2.5% during the forecast period. This growth is driven by the increasing demand for managing type 2 diabetes, particularly in reducing postprandial hyperglycemia and glucose variability throughout the day[2].

Key Players

Major companies operating in the North America alpha-glucosidase inhibitors market include Takeda, Pfizer, Bayer, Sunpharma, and Glenmark. These companies play a significant role in the production, distribution, and marketing of acarbose and other alpha-glucosidase inhibitors[2].

Market Segmentation

The market is segmented by geography, with the United States being the largest market due to its high prevalence of diabetes. The market is also segmented by type, with acarbose (Precose) and miglitol (Glyset) being the primary drugs in this category[2].

Projections and Future Outlook

Global Market Insights

The global acarbose market is expected to see steady growth, driven by increasing awareness and the need for effective diabetes management. A market research report forecasts the global acarbose market to continue its upward trend, with detailed insights and forecasts up to 2030[5].

Emerging Therapeutic Uses

Beyond its traditional use in diabetes, acarbose is being explored for other therapeutic applications. The ongoing trial in advanced renal cell carcinoma is a prime example of this expansion. Successful outcomes in such trials could significantly broaden the market for acarbose and increase its demand[1].

Cardio-Protective Effects and Guidelines

Acarbose has been recognized for its cardio-protective effects, particularly in reducing the risk of myocardial infarction and other cardiovascular events. International guidelines have recently recommended acarbose as an alternative first-line antidiabetic therapy, especially in the Asian population, due to these benefits[3].

Key Takeaways

• Clinical Efficacy: Acarbose has been shown to improve glycemic control and reduce cardiovascular risks in patients with type 2 diabetes.
• Market Growth: The North America alpha-glucosidase inhibitors market is projected to grow from USD 0.28 billion in 2024 to USD 0.32 billion by 2029.
• Emerging Uses: Acarbose is being explored for use in advanced renal cell carcinoma, potentially expanding its therapeutic applications.
• Side Effects: While effective, acarbose can cause side effects like flatulence and diarrhea, necessitating careful titration.
• Guidelines: Acarbose is recommended as an alternative first-line therapy for type 2 diabetes due to its cardio-protective effects.

FAQs

What is the primary use of acarbose?

Acarbose is primarily used to treat type 2 diabetes mellitus by delaying the absorption of carbohydrates in the intestines.

What are the cardiovascular benefits of acarbose?

Acarbose has been shown to reduce the risk of myocardial infarction by 64% and any cardiovascular event by 35% in patients with type 2 diabetes[3].

What is the current market size of the North America alpha-glucosidase inhibitors market?

The North America alpha-glucosidase inhibitors market size is estimated at USD 0.28 billion in 2024[2].

Who are the major players in the North America alpha-glucosidase inhibitors market?

Major players include Takeda, Pfizer, Bayer, Sunpharma, and Glenmark[2].

What are the common side effects of acarbose?

The most common side effects of acarbose are flatulence and diarrhea[4].

Sources

1. CTV.Veeva.com: Acarbose in Combination With Standard Therapy in Metastatic Renal Cell Carcinoma (RCC)
2. Mordor Intelligence: North America Alpha-Glucosidase Inhibitors Market Size
3. Journal of Clinical Endocrinology and Metabolism: Cardiovascular Risk Associated With Acarbose Versus Metformin as Initial Therapy in Type 2 Diabetes
4. PubMed: A Randomized Double-Blind Trial of Acarbose in Type 2 Diabetes
5. Market Research Reports: Global Acarbose Market Insights, Forecast to 2030

Last updated: 2025-01-01