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.

Clinical Trial Conditions for PRECOSE

Condition Name

Condition Name for PRECOSE
Intervention	Trials
Type 2 Diabetes Mellitus	3
Other Specified Hypotension	1
Pediatric Obesity	1
Syncope	1

Condition MeSH

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

Clinical Trial Locations for PRECOSE

Trials by Country

Trials by Country for PRECOSE
Location	Trials
United States	5
Canada	1
China	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
Indiana University School of Medicine	1
Bastyr University	1
Kenneth Madden	1

Sponsor Type

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

Last updated: April 28, 2026

Precose (acarbose): clinical-trial status, market analysis, and projection

What is Precose and what is its current clinical footprint?

Precose is the brand name of acarbose (an alpha-glucosidase inhibitor) used for the management of type 2 diabetes mellitus. The drug’s clinical development history is mature, and current activity centers on (1) regulatory labeling maintenance, (2) new evidence generation in diabetes care standards, and (3) post-authorization comparative or mechanistic studies rather than de novo late-stage registrational programs.

Clinical-trial update (activity type)

• Registrational (Phase 3/Phase 2 pivotal) pipeline: No active Phase 3/late-stage registrational program is evidenced for Precose/acarbose in major trial registries at the level typically associated with fresh label expansion.
• Ongoing trial pattern: Research activity is more commonly concentrated in smaller mechanistic, comparative, or real-world evidence studies, often involving acarbose within broader diabetes treatment frameworks.

Implication for developers and investors

• The near-term clinical narrative for Precose is driven by evidence maintenance and real-world outcomes rather than new regulatory endpoints or label expansions.
• Commercial upside depends more on market access, formularies, payer behavior, and competitive positioning than on catalysts from new Phase 3 readouts.

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What is the market for acarbose and where does Precose sit?

Acarbose is an older, off-patent diabetes therapy with generic competition in multiple jurisdictions. In the US, Precose is a branded product historically marketed through Takeda’s legacy and successor structures, but acarbose’s therapeutic class faces pricing pressure typical of long-cycle molecules with generic availability.

Market drivers

• Chronic-disease demand: Type 2 diabetes incidence and prevalence support steady baseline demand for oral combination regimens.
• Class competition: Incretin-based agents (GLP-1 and dual agonists) and SGLT2 inhibitors dominate the high-growth segment, shifting some volume away from older oral agents.
• Payer behavior: Older oral drugs maintain value in formularies tied to cost containment, especially where formulary tiers and prior authorization limit access to newer classes.
• Safety and tolerability: Acarbose’s GI adverse event profile affects adherence and payer utilization policies.

What this means for Precose

• Precose competes primarily on cost-effectiveness, formulary placement, and tolerability management rather than on novelty.
• The brand’s market share is constrained by generic substitutions where allowed and by the relative uptake of faster-growing modern agents.

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How does Precose’s competitive landscape shape pricing and utilization?

Key competitive sets (therapy and class)

• Older oral options: metformin, sulfonylureas, thiazolidinediones.
• Newer oral and injectable options: DPP-4 inhibitors, GLP-1 receptor agonists, dual incretin agents, SGLT2 inhibitors, insulin therapies.
• Within-class comparators: acarbose competitors are limited by the molecule, but therapeutic alternatives compete for the same HbA1c target space.

Utilization dynamics

• Payers often prefer newer agents when outcomes data and coverage policies align, but older oral drugs remain in active formularies due to budget impact.
• Real-world prescribing trends frequently reflect step-therapy logic: older inexpensive agents appear early; incretin and SGLT2 agents appear later when coverage and clinical guidance permit.

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What do market projections look like for Precose through the medium term?

Acarbose is a mature, generic-drivable product category. Under typical market mechanics for older diabetes drugs, the base case is:

• Volume stability with price erosion where generics dominate.
• Modest net revenue growth or decline depending on brand-specific pricing, exclusivity remnants (if any), and retention via specialty channels.

Projection framework (three-part)

1. Total addressable market (TAM): Type 2 diabetes treated population grows slowly with aging and disease prevalence.
2. Share dynamics: Share trends depend on substitution by newer classes.
3. Price dynamics: Brand pricing declines relative to generics and discounted channels; net revenue growth is limited unless brand retains differentiated access or pricing leverage.

Base-case directional forecast (market level)

• No high-probability expansion from new clinical outcomes because the drug is not positioned for new registrational catalysts.
• Expected trend: steady demand with continued pressure from modern diabetes drug uptake and generic substitution.

Because Precose is an off-patent product, projections are best expressed as directional rather than as fresh, earnings-style forecasts. The market will behave like a mature category with persistent churn from innovation uptake.

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What investment and business decisions should follow from this profile?

For R&D

• If evaluating line-extensions or new combinations, focus on clinical differentiation routes that can change payer behavior: adherence, GI side effect mitigation, or evidence tailored to budget-impact models.
• Absent a new registrational path, the ROI case favors either:
  • life-cycle evidence generation that supports formulary value; or
  • fixed-dose combinations if feasible and registrable in relevant markets.

For BD and licensing

• Brand value is mostly commercial execution: channel contracts, payer inclusion, inventory stability, and manufacturing economics.
• License value is constrained if generic competition is strong in the target jurisdiction.

For pricing and access

• Emphasize health-economic evidence and patient-selection criteria that improve tolerability and persistence.
• Build payer messaging around total regimen cost and step-therapy alignment.

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Key Takeaways

• Precose (acarbose) is a mature, off-patent diabetes drug with limited near-term clinical catalysts typical of new registrational programs.
• Market growth is structurally capped by generic substitution and ongoing uptake of higher-growth diabetes therapies (GLP-1 and SGLT2 classes).
• Brand outcomes hinge on formulary access, payer behavior, and adherence management, not on Phase 3-style innovation.
• Medium-term outlook is stable-to-pressured: volume durability may coexist with pricing pressure and share loss to newer drug classes.

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FAQs

1. Is Precose expected to have new Phase 3 registrational trials?
   Activity is more consistent with maintenance and non-pivotal evidence generation than with new registrational late-stage trials.

2. What drives payer coverage decisions for acarbose/Precose?
   Formularies and step therapy, cost-effectiveness versus alternatives, and tolerability-informed patient selection.

3. How does generic competition affect Precose economics?
   It compresses brand pricing power and can shift demand to lower-cost alternatives where substitution is allowed.

4. How do newer diabetes drugs impact acarbose utilization?
   They compete for similar HbA1c treatment space, shifting prescribing patterns toward incretin and SGLT2 classes when covered.

5. What is the most realistic value lever for Precose going forward?
   Real-world evidence and access strategy that improve retention within payer formularies and support persistence despite GI tolerability constraints.

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References

[1] ClinicalTrials.gov. Study records for acarbose. https://clinicaltrials.gov/
[2] FDA. Precose (acarbose) prescribing information. https://www.accessdata.fda.gov/