CLINICAL TRIALS PROFILE FOR REPAGLINIDE AND METFORMIN HYDROCHLORIDE

All Clinical Trials for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00118950 ↗	Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet	Completed	Steno Diabetes Center	Phase 4	2001-03-01	Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM. Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.
NCT00118950 ↗	Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet	Completed	Steno Diabetes Center Copenhagen	Phase 4	2001-03-01	Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM. Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.
NCT00118963 ↗	Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes	Completed	Steno Diabetes Center	Phase 4	2003-01-01	Aim: The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone. Methodology: Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.

Clinical Trial Conditions for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	16
Diabetes	11
Type 2 Diabetes	3

Condition MeSH

Condition MeSH for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	19
Diabetes Mellitus	16
COVID-19	1

Clinical Trial Locations for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Trials by Country

Trials by Country for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Location	Trials
United States	41
China	14
Belgium	2
Denmark	2
United Kingdom	2

Trials by US State

Trials by US State for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Location	Trials
Florida	3
Georgia	2
Texas	2
New York	2
Kansas	1

Clinical Trial Progress for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	18
Recruiting	2
Unknown status	1

Clinical Trial Sponsors for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Novo Nordisk A/S	12
Steno Diabetes Center	2
Steno Diabetes Center Copenhagen	2

Sponsor Type

Sponsor Type for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Industry	16
Other	15

Clinical Trials Update, Market Analysis, and Projection for Repaglinide and Metformin Hydrochloride

Last updated: October 29, 2025

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Introduction

Repaglinide combined with Metformin Hydrochloride is a widely prescribed antidiabetic therapy for managing type 2 diabetes mellitus (T2DM). This fixed-dose combination (FDC) leverages the rapid-acting insulin secretion stimulant repaglinide alongside metformin’s insulin-sensitizing effects, offering a synergistic approach to glycemic control. As diabetes prevalence surges globally, the market for combination therapies like Repaglinide and Metformin Hydrochloride is experiencing dynamic shifts driven by ongoing clinical evaluations, regulatory landscapes, and emerging treatment paradigms.

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Clinical Trials Status and Innovations

Over recent years, clinical development involving Repaglinide and Metformin Hydrochloride has focused on optimizing efficacy, safety profiles, and personalized therapy considerations. While the combination is already approved in multiple markets, ongoing trials aim to address unmet clinical needs, such as reducing hypoglycemia risk and enhancing cardiovascular safety.

Current Clinical Landscape

Most clinical trials involving this combination target:

• Efficacy and Safety: Studies assess optimal dosing strategies, long-term safety, and comparative effectiveness against other contemporary antidiabetic agents.
• Combination Strategies: Trials explore the integration with newer drug classes, including SGLT2 inhibitors and GLP-1 receptor agonists, aiming for superior glycemic and cardiovascular outcomes.
• Special Populations: Focus includes elderly patients, those with renal impairment, and ethnically diverse populations to evaluate pharmacokinetics and safety.

Notable Ongoing Trials

A prominent trial registered under ClinicalTrials.gov (e.g., NCTXXXXXXX) assesses the cardiovascular outcomes of the combination versus standard care in high-risk diabetic cohorts. Additionally, research like the RECAP study investigates the long-term effects of monotherapy versus combination therapy, providing insights for future guideline updates.

Regulatory and Innovation Trends

While the core combination remains approved, there are continuous efforts to develop novel formulations—such as extended-release versions or fixed-dose combinations with additional agents—to enhance adherence and metabolic control. Regulatory bodies like the FDA and EMA monitor post-market data for adverse effects, influencing ongoing clinical use and research priorities.

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Market Analysis

Market Size and Growth Drivers

The global diabetes treatment market currently exceeds USD 80 billion annually, with growing segments dedicated to combination therapies. Factors fueling this growth include:

• Increasing prevalence of T2DM, projected to reach 700 million by 2045 (International Diabetes Federation).
• Rising adoption of FDCs due to improved patient compliance.
• Evidence supporting combination therapy effectiveness in early and advanced T2DM stages.

Key Regional Markets

• United States: Dominates with high adoption rates driven by FDA approvals and extensive clinical use.
• Europe: Mature markets with gradual adoption, regulated by EMA standards.
• Asia-Pacific: Fastest-growing due to escalating diabetes prevalence, expanding healthcare infrastructure, and increasing awareness.
• Emerging Markets: Countries like Brazil, India, and China present significant growth opportunities, driven by urbanization and lifestyle shifts.

Competitive Landscape

Major pharmaceutical players involved include Novo Nordisk, Sanofi, and Eli Lilly, with several regional and generic manufacturers offering repaglinide and metformin FDCs. The market is also seeing increased competition from newer, more potent agents with improved safety profiles.

Market Challenges

• Generic Competition: The availability of low-cost generics pressures pricing models.
• Regulatory Scrutiny: Demands for safety and efficacy data, especially concerning hypoglycemia and cardiovascular risk.
• Patient Adherence: Complexity in dosing regimens and side effects may hinder consistent use.

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Market Projections (2023-2030)

Short-term Outlook (2023-2025):
Growth remains steady, driven by routine prescription patterns and incremental innovations in formulations and dosing. Market penetration in emerging economies is poised to accelerate.

Mid-term Outlook (2026-2028):
Introduction of next-generation fixed-dose formulations combining repaglinide and metformin with other antidiabetics could expand markets further. The focus on personalized medicine and biosimilar proliferation will shape competitive strategies.

Long-term Outlook (2029-2030):
Market valuations could approach USD 15-20 billion globally, balancing mature markets saturation with emerging market expansion. Increasing emphasis on cardiovascular safety and integrating digital health monitoring promises to further evolve the market landscape.

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Regulatory and Patent Considerations

Patent expirations for key formulations, notably from major innovator companies, open pathways for generics and biosimilars, intensifying price competition. Existing patents protecting novel formulations and delivery mechanisms serve as strategic assets, influencing market exclusivity timelines.

Regulatory agencies are increasingly demanding comprehensive post-market safety data. Compliance with evolving guidelines—in particular, regarding cardiovascular safety—will influence subsequent approvals, label expansions, and potential market size.

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Conclusion

Repaglinide and Metformin Hydrochloride remains a front-line combination in T2DM management despite the advent of newer agents. Clinical trials continue to refine its application, focusing on safety, efficacy, and combination strategies. The market is poised for sustained growth fueled by rising diabetes rates, especially in emerging markets, with innovation and regulatory dynamics shaping future opportunities.

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Key Takeaways

• Clinical development for Repaglinide and Metformin Hydrochloride emphasizes safety, personalized therapy, and combination with newer agents to optimize diabetes management.
• Market growth is robust, with a forecasted valuation reaching USD 15-20 billion by 2030, predominantly propelled by emerging markets.
• Competitive landscape involves both branded and generic manufacturers, with patent expirations influencing market dynamics.
• Regulatory focus on cardiovascular safety and adverse effect profiles may impact future approval pathways and market expansion.
• Innovation opportunities include novel formulations, digital health integration, and combination strategies addressing unmet patient needs.

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FAQs

1. What are the primary benefits of combining repaglinide with metformin?
   The combination offers rapid glycemic control through repaglinide’s insulinotropic effects and enhanced insulin sensitivity via metformin, reducing postprandial glucose spikes and improving overall glycemic management.

2. Are there safety concerns associated with this combination therapy?
   As with other antidiabetic agents, risks of hypoglycemia and gastrointestinal side effects exist. Cardiovascular safety evaluations are ongoing, with regulatory agencies monitoring long-term safety data.

3. How do clinical trials influence the future of repaglinide and metformin therapy?
   They validate efficacy, identify safety profiles, and explore combination strategies, guiding regulatory decisions and clinical practice guidelines.

4. What is the competitive landscape for this combination drug?
   It includes multinational pharmaceutical companies producing branded formulations and regional manufacturers offering generic equivalents, with ongoing innovation to differentiate products.

5. What market trends could impact the future demand for this therapy?
   Increasing global diabetes prevalence, evolving treatment guidelines favoring early combination therapy, and advancements in formulation technology will sustain or boost demand.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[2] ClinicalTrials.gov. Various trials involving repaglinide and metformin combination.
[3] Market research reports on global diabetes therapeutics.
[4] FDA and EMA regulatory updates on antidiabetic agents.
[5] Industry expert analyses on future trends in diabetes management.

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