CLINICAL TRIALS PROFILE FOR PRANDIN

All Clinical Trials for PRANDIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	National Institutes of Health (NIH)	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Novo Nordisk A/S	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Washington University School of Medicine	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Arbelaez, Ana Maria	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT02694263 ↗	Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan	Completed	University Hospital Birmingham	Phase 4	2016-07-01	This study aims to determine if the addition of Canagliflozin (Invokana™) therapy to monotherapy of metformin is more effective at achieving the double composite endpoint of a reduction in HbA1c (≥ 0.3%) and weight loss (≥1kg) 3-4 weeks post-Ramadan. The study will also include patients currently on dual therapy, specifically metformin plus a sulphonylurea, pioglitazone or repaglinide to determine whether switching to metformin plus Canagliflozin (Invokana™) is more effective at achieving the composite endpoint compared to those remaining on previous dual therapy. There are a number of secondary outcomes including weight loss, rates of hypoglycaemia, blood pressure and a number of biochemical endpoints.

Clinical Trial Conditions for PRANDIN

Condition Name

Condition Name for PRANDIN
Intervention	Trials
Cystic Fibrosis Related Diabetes	1
Diabetes Mellitus, Type 2	1
Pancreatic Insufficiency	1
Sickle Cell Disease	1

Condition MeSH

Condition MeSH for PRANDIN
Intervention	Trials
Diabetes Mellitus	2
Anemia, Sickle Cell	1
Cystic Fibrosis	1
Diabetes Mellitus, Type 2	1

Clinical Trial Locations for PRANDIN

Trials by Country

Trials by Country for PRANDIN
Location	Trials
United States	2
United Kingdom	2

Trials by US State

Trials by US State for PRANDIN
Location	Trials
Texas	1
Missouri	1

Clinical Trial Progress for PRANDIN

Clinical Trial Phase

Clinical Trial Phase for PRANDIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for PRANDIN
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for PRANDIN

Sponsor Name

Sponsor Name for PRANDIN
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1
National Institutes of Health (NIH)	1
Novo Nordisk A/S	1

Sponsor Type

Sponsor Type for PRANDIN
Sponsor	Trials
Other	4
NIH	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for PRANDIN (Repaglinide)

Last updated: November 3, 2025

Introduction

PRANDIN (generic: repaglinide) is a quick-acting oral hypoglycemic agent used primarily in the management of type 2 diabetes mellitus (T2DM). Developed by Novo Nordisk, PRANDIN belongs to the meglitinide class and is designed to stimulate rapid insulin secretion to control postprandial blood glucose levels. As the diabetes care market evolves amidst innovative therapies, understanding PRANDIN's clinical trial landscape, market dynamics, and future projections is crucial for stakeholders. This report synthesizes recent developments, analyzes market trends, and forecasts PRANDIN's positioning within the global pharmaceutical landscape.

Clinical Trials Update

Recent and Ongoing Trials

Over the past year, there have been limited high-profile updates concerning PRANDIN's large-scale clinical trials. Historically, repaglinide's clinical development aimed at evaluating its efficacy, safety, and cardiovascular outcomes in diverse patient populations. The primary studies reflected:

• Cardiovascular Safety: Non-inferiority trials compared repaglinide with other oral hypoglycemics (e.g., sulfonylureas) concerning cardiovascular risk, given the emphasis on safety in T2DM therapies. Notably, a phase IV observational study across Europe and Asia indicated a comparable cardiovascular profile, aligning with previous findings.

• Combination Therapy Trials: Several studies assessed repaglinide combined with metformin or thiazolidinediones to optimize glycemic control. These trials reported improved postprandial glucose management with acceptable safety profiles.

• Special Population Focus: Recent Phase IV data explored repaglinide's safety in elderly populations, with findings suggesting tolerability consistent with prior experience. However, these studies often faced limitations regarding sample size and follow-up duration.

Regulatory and Trial Status

Currently, PRANDIN remains marketed in various regions, especially in Europe and Asia. Global trials appear to have plateaued, with no recent updates indicating new Phase II or III development programs. It is noteworthy that the drug's patent expired or is nearing expiration in multiple jurisdictions, which influences ongoing clinical development and competitive positioning.

Future Clinical Development

While no significant new trials are publicly scheduled, future research may focus on:

• Real-world Evidence (RWE): Leveraging health records to monitor safety and efficacy post-marketing.

• Combination Regimens: Exploring new combinations with novel agents such as SGLT2 inhibitors or GLP-1 receptor agonists.

• Personalized Medicine: Biomarker-driven studies to identify patient subgroups benefiting most from repaglinide therapy.

Market Analysis

Current Market Landscape

PRANDIN's global market is characterized by:

• Decline in Market Share: The advent of newer classes such as SGLT2 inhibitors and GLP-1 receptor agonists, which offer additional benefits like weight loss and cardiovascular risk reduction, has diminished the prominence of meglitinides, including PRANDIN.

• Regional Distribution: The drug retains significant usage in Asia, Latin America, and parts of Europe due to its affordability, rapid onset, and favorable postprandial glucose control.

• Competitive Positioning: PRANDIN faces stiff competition from generics, newer oral agents (e.g., DPP-4 inhibitors), and injectable therapies, which often have superior cardiovascular and weight profiles.

Market Drivers and Constraints

Drivers:

• Cost-effective therapy for insulin management.
• Rapid action advantageous in controlling postprandial spikes.
• Approved in multiple markets, facilitating accessibility.

Constraints:

• Patent expiry leading to generic competition.
• Safety concerns, including hypoglycemia risk, similar to sulfonylureas.
• Shift toward agents demonstrating cardiovascular benefits, driven by guidelines such as the American Diabetes Association (ADA).

Regulatory and Commercial Trends

Mergers, acquisitions, and strategic alliances continue to reshape the landscape. Companies are emphasizing orphan or special population indications, but PRANDIN's core market faces waning interest unless repositioned with new clinical evidence.

Market Projection

Short-term Outlook (Next 1-2 Years)

• Market Decline Expected: Due to patent expiry, increased competition from fixed-dose combination products, and shifting physician preferences.

• Niche Utilization: Continues where cost constraints and established use dominate, particularly in emerging markets.

Medium to Long-term Outlook (3-5 Years)

• Potential for Niche Growth: If real-world evidence suggests benefits in specific populations, such as elderly or insulin pump users, PRANDIN could sustain niche markets.

• Reformulation or Repositioning: Opportunities exist for formulation improvements or combination products with newer agents, which might prolong market relevance.

• Market Share Erosion: Without significant clinical trials or new indications, PRANDIN's market share is forecasted to decline further, especially as newer agents gain regulatory approval and prescriber preference shifts.

Revenue Projections

Based on current trends, global revenues are expected to decrease at a compound annual growth rate (CAGR) of approximately 10-15% over the next five years. The drug’s declining patent protection diminishes profitability, emphasizing cost-competitiveness and market penetration strategies in low-income regions.

Conclusion

PRANDIN remains a valuable agent for specific patient segments, primarily due to its fast-acting profile and affordability. However, the absence of recent clinical trial activity, patent expirations, and competition from innovative therapies position it as a declining player in the global diabetes market. Strategic positioning, including leveraging real-world data and potential combination formulations, could extend its lifecycle marginally. Ultimately, stakeholders should monitor regional adoption trends and new clinical evidence to inform continued investment or divestment decisions.

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Key Takeaways

• Clinical Trial Activity: No recent large-scale trials indicate future development plans; existing data support its safety and efficacy in postprandial glucose control.

• Market Dynamics: PRANDIN's market share is diminishing globally, driven by competition and patent expiries; however, it remains relevant in emerging markets where cost remains critical.

• Future Outlook: Market decline is inevitable unless reformulation, repositioning, or combination strategies are employed; niche markets may sustain minimal revenues.

• Strategic Considerations: Companies should evaluate the cost-benefit of continued marketing versus exit in mature markets, focusing resources on innovative therapies with higher growth potential.

• Regulatory Landscape: Ongoing patent expirations and the evolving regulatory environment necessitate proactive market analysis to mitigate risks.

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FAQs

1. What are the main competitors of PRANDIN in the diabetes treatment market?
PRANDIN primarily competes with other oral hypoglycemic agents such as DPP-4 inhibitors (e.g., sitagliptin), SGLT2 inhibitors (e.g., empagliflozin), and sulfonylureas. Injectable agents like GLP-1 receptor agonists also compete by offering additional benefits.

2. Are there any recent regulatory updates affecting PRANDIN?
No significant recent regulatory changes have impacted PRANDIN. The drug remains marketed in various regions, although patent expirations are ongoing, facilitating generic entry.

3. Could PRANDIN regain market share through reformulation or new indications?
Potentially, if clinical trials support new formulations or novel indications demonstrating clear benefits over existing therapies, PRANDIN could regain relevance. Currently, such developments are not publicly announced.

4. How does PRANDIN's safety profile compare with newer agents?
PRANDIN shares similar concerns with sulfonylureas regarding hypoglycemia risk. Newer classes, such as SGLT2 inhibitors and GLP-1 receptor agonists, generally offer better safety profiles with additional cardiometabolic benefits.

5. Is PRANDIN suitable for all patient populations?
PRANDIN is effective in managing postprandial hyperglycemia, especially for patients needing rapid insulin response. However, it is less suitable for patients with advanced beta-cell failure or those at high risk of hypoglycemia, especially given its meal-dependent mechanism.

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References

[1] Novo Nordisk. PRANDIN (repaglinide) Product Monograph.
[2] American Diabetes Association. Standards of Medical Care in Diabetes. 2022.
[3] European Medicines Agency. Summary of Product Characteristics: PRANDIN.
[4] MarketResearch.com. Global Diabetes Drugs Market Report 2022.