CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE; REPAGLINIDE

All Clinical Trials for metformin hydrochloride; repaglinide

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.
NCT00118963 ↗	Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes	Completed	Steno Diabetes Center Copenhagen	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.
NCT00399711 ↗	Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2006-11-01	This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.
NCT00491725 ↗	Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs	Completed	Novo Nordisk A/S	Phase 4	2005-09-01	This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

Clinical Trial Conditions for metformin hydrochloride; repaglinide

Condition Name

Condition Name for metformin hydrochloride; repaglinide
Intervention	Trials
Diabetes Mellitus, Type 2	16
Diabetes	11
Type 2 Diabetes	3
Covid19	1

Condition MeSH

Condition MeSH for metformin hydrochloride; repaglinide
Intervention	Trials
Diabetes Mellitus, Type 2	19
Diabetes Mellitus	16
Renal Insufficiency, Chronic	1
Kidney Diseases	1

Clinical Trial Locations for metformin hydrochloride; repaglinide

Trials by Country

Trials by Country for metformin hydrochloride; repaglinide
Location	Trials
United States	41
China	14
United Kingdom	2
Belgium	2
Denmark	2

Trials by US State

Trials by US State for metformin hydrochloride; repaglinide
Location	Trials
Florida	3
New York	2
Georgia	2
Texas	2
South Carolina	1

Clinical Trial Progress for metformin hydrochloride; repaglinide

Clinical Trial Phase

Clinical Trial Phase for metformin hydrochloride; repaglinide
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for metformin hydrochloride; repaglinide
Clinical Trial Phase	Trials
Completed	18
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for metformin hydrochloride; repaglinide

Sponsor Name

Sponsor Name for metformin hydrochloride; repaglinide
Sponsor	Trials
Novo Nordisk A/S	12
Steno Diabetes Center Copenhagen	2
Steno Diabetes Center	2

Sponsor Type

Sponsor Type for metformin hydrochloride; repaglinide
Sponsor	Trials
Industry	16
Other	15

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

Last updated: October 28, 2025

Introduction

Metformin Hydrochloride and Repaglinide are cornerstone agents in the management of type 2 diabetes mellitus (T2DM). With the global diabetes pandemic escalating, both drugs continue to experience significant clinical and commercial relevance. This analysis provides a comprehensive update on ongoing and recent clinical trials, evaluates current market dynamics, and projects future growth trajectories for these therapeutic agents.

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Clinical Trials Landscape: Current Updates and Developments

Metformin Hydrochloride

Metformin remains the first-line oral hypoglycemic agent recommended by international guidelines such as the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD). Recent clinical trials focus on expanding its therapeutic potential beyond glycemic control, investigating its cardioprotective, anticancer, and anti-aging effects.

• Recent Clinical Trials:
  An ongoing trial (NCT04527396) from 2020 explores Metformin's role in reducing cardiovascular events in high-risk populations. Similarly, NCT03291737 examines its efficacy in reducing cancer incidence among diabetic patients, reflecting the drug's emerging role in oncological prevention.

• Formulation Innovations:
  Clinical evaluations of extended-release formulations and combination products, such as Metformin with Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors, are underway to improve tolerability and adherence.

Repaglinide

Repaglinide, a meglitinide class agent, offers rapid, short-acting insulin secretion, making it especially useful in postprandial glucose management. Recent trials are examining its comparative efficacy and safety alongside other newer incretin-based therapies.

• Recent Clinical Trials:
  The phase IV trial NCT04597531 evaluates Repaglinide's glucose-lowering efficacy in elderly patients with renal impairment—a subgroup requiring cautious dosing. Another study assesses its combination with DPP-4 inhibitors to optimize post-meal glycemic spikes.

• Novel Formulations and Combinations:
  Trials are increasingly evaluating fixed-dose combinations (FDCs) involving Repaglinide with agents like Metformin, aiming to enhance patient compliance and simplify regimens.

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Market Overview and Dynamics

Global Market Size and Growth

The global diabetes drugs market was valued at approximately USD 57.3 billion in 2021 and is projected to reach USD 95.4 billion by 2028, expanding at a CAGR of 7.4% [1]. Metformin dominates as the most prescribed antidiabetic agent, commanding nearly 35-40% of the market share, owing to its efficacy, safety profile, and cost-effectiveness.

Repaglinide's market presence remains more niche, mainly constrained to specific indications and regions due to competition with other agents like DPP-4 inhibitors and SGLT2 inhibitors. Nonetheless, it maintains steady demand, especially in centers emphasizing short-acting insulin secretion.

Market Drivers

• Rising Diabetes Prevalence:
  The International Diabetes Federation estimates 537 million adults with diabetes worldwide in 2021—a number expected to reach 643 million by 2030 [2]. The proliferation amplifies demand for established medications like Metformin and Repaglinide.

• Cost-Effectiveness and Generics:
  As generic formulations of Metformin and Repaglinide remain affordable, especially in emerging markets, they sustain broad usage, bolstering volume sales.

• Expanding Indications:
  Emerging evidence of Metformin's benefits in prediabetes, aging, and oncology expands its market beyond traditional glycemic control, fostering product diversification.

Competitive Landscape

The market features numerous established pharmaceutical companies, including Merck, Novo Nordisk, and AstraZeneca, alongside generic producers. Novel agents—GLP-1 receptor agonists and SGLT2 inhibitors—capture increasing market share due to superior efficacy in cardiovascular outcomes but compete with the safety and cost profile of Metformin and Repaglinide.

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Market Projections and Future Trends

Growth Outlook (2023-2030)

• Metformin Hydrochloride:
  Projected to sustain its leadership position, with compounded annual growth of around 4-5%. Driven by ongoing clinical research supporting its expanded use in preventative and adjunctive therapy, as well as formulations enhancing tolerability.

• Repaglinide:
  Expected to experience moderate growth with a CAGR of 2-3%. Focused primarily on niche markets, especially in regions with limited access to newer therapies. Its role in combination therapies and tailored regimens will influence its market stability.

Innovations and Future Opportunities

• Formulation Developments:
  Extended-release and fixed-dose combinations are poised to increase adherence and expand marketability.

• Digital and Personalized Medicine:
  Integration with digital health tools and tailoring therapies based on genetic/metabolic profiles could carve new niches for these agents.

• Regulatory and Patent Dynamics:
  Patent expirations of brand-name formulations pave the way for generics, further lowering prices and expanding access.

Challenges and Risks

• Competition from novel, more efficacious agents with proven cardiovascular benefits could erode market share.
• Safety concerns, especially with Repaglinide's hypoglycemia risk, may influence prescribing patterns.
• Regulatory shifts and reimbursement policies can impact accessibility and profitability.

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Conclusion

Metformin hydrochloride solidifies its position as the foundational T2DM therapy, with ongoing clinical trials exploring expanded indications and improved formulations. Repaglinide remains relevant particularly within specific patient populations and regions, with steady but moderate growth prospects.

Anticipated innovation, combined with the ongoing diabetes epidemic, supports sustained demand for these agents. Strategic focus on formulation enhancements, combination therapies, and leveraging emerging clinical evidence will be crucial for stakeholders aiming to optimize market penetration and therapeutic outcomes.

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Key Takeaways

• Metformin remains the dominant first-line therapy, with clinical research extending its utility in cardiovascular, oncological, and geriatric domains.

• Repaglinide's niche role persists, primarily in postprandial glucose management, with growth driven by combination therapies and targeted use in specific subgroups.

• Market growth projections favor continued dominance by Metformin, supported by its affordability, safety, and broad clinical utility, despite stiff competition from newer agents.

• Innovation in formulations and combination therapies will be essential to enhance adherence, efficacy, and patient outcomes.

• Regulatory, patent, and competitive dynamics will shape the evolution of both drugs' market landscape over the coming years.

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FAQs

1. Will the clinical trials support broader indications for Metformin?
Yes. Current trials investigating its role in cardiovascular disease, aging, and cancer may lead to expanded indications if outcomes prove favorable and regulatory approvals are aligned.

2. How does Repaglinide compare with newer agents like DPP-4 inhibitors?
Repaglinide offers rapid, short-term insulin secretion, suitable for post-meal control but generally lacks the additional benefits (e.g., cardiovascular safety) associated with newer classes like DPP-4 inhibitors, which are often preferred for their safety profiles.

3. What are the main barriers to market growth for these drugs?
The primary barriers include competition from novel therapies, safety concerns (particularly hypoglycemia with Repaglinide), and regulatory shifts that favor innovative mechanisms of action.

4. Are there upcoming formulations that could change the market dynamics?
Yes. Extended-release formulations and fixed-dose combinations are in development, promising improved adherence and patient convenience, potentially influencing future prescribing patterns.

5. How do regional differences affect the market for Metformin and Repaglinide?
Emerging markets with limited access to costly newer agents prioritize affordable alternatives like Metformin and Repaglinide. In contrast, developed regions often favor newer therapies with proven cardiovascular benefits, impacting regional market shares.

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References

1. Allied Market Research. (2022). Global Diabetes Drugs Market Size, Growth, and Forecast.
2. International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.