CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE; REPAGLINIDE

All Clinical Trials for METFORMIN HYDROCHLORIDE; REPAGLINIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

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

Condition MeSH

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

Clinical Trial Locations for METFORMIN HYDROCHLORIDE; REPAGLINIDE

Trials by Country

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

Trials by US State

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Trials by US State for METFORMIN HYDROCHLORIDE; REPAGLINIDE
Location	Trials
Florida	3
Georgia	2
Texas	2
New York	2
Kansas	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	2
Steno Diabetes Center Copenhagen	2

Sponsor Type

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

Metformin Hydrochloride and Repaglinide: Clinical Trials, Market Analysis, and Projections

Introduction to Metformin Hydrochloride and Repaglinide

Metformin hydrochloride and repaglinide are two significant drugs in the management of diabetes, particularly type 2 diabetes. Here, we will delve into the current clinical trials, market analysis, and projections for these medications.

Clinical Trials Update for Metformin Hydrochloride

Expanding Applications of Metformin

Metformin hydrochloride, traditionally used for managing type 2 diabetes, is being explored for its potential in various other medical conditions. Here are some key clinical trials:

• Multiple Sclerosis (MS): Several clinical trials are investigating the efficacy of metformin as an add-on treatment for MS. A multicenter, randomized, triple-blind, placebo-controlled trial is underway to evaluate whether metformin can delay disease progression in patients with progressive MS. The trial focuses on outcomes such as walking speed, MS-related disability, hand function, and cognitive function[4].

• Cardiovascular and Anti-Aging Benefits: Studies have suggested that metformin may offer cardiovascular benefits and potentially slow the aging process. Ongoing investigations aim to confirm these findings and explore its role in reducing the risk of cancer, stroke, and dementia in patients with type 2 diabetes[1].

• Other Conditions: Metformin is also being studied for its potential in treating other conditions beyond diabetes, including its effects on oxidative stress and its role as an adjuvant therapy in various diseases.

Clinical Trials Update for Repaglinide

Repaglinide in Diabetes Management

Repaglinide, a meglitinide class drug, is used to treat non-insulin-dependent diabetes mellitus (NIDDM). Here are some key points about its clinical use:

• Mechanism of Action: Repaglinide stimulates insulin release from the pancreatic β cells, particularly in response to meals, reducing postprandial blood glucose levels. It is taken with meals and skipped if a meal is skipped to avoid hypoglycemia[3].

• Current Use: While repaglinide is not as widely studied in new clinical trials as metformin, it remains a viable option for managing blood glucose levels, especially in patients who require meal-time insulin stimulation.

Market Analysis for Metformin Hydrochloride

Global Market Size and Growth

The global metformin hydrochloride market is experiencing significant growth driven by several factors:

• Market Size: The market was valued at approximately USD 268.95 million in 2022 and is projected to grow to USD 386.91 million by 2030, with a CAGR of 4.7% during the forecast period[1].

• Regional Dominance: The Asia-Pacific region is expected to lead the market due to the high prevalence of type 2 diabetes in countries like China and India. Over 140 million people in China and 135 million people in India are diagnosed with diabetes or prediabetes, contributing to the market growth[1].

• Drivers: The increasing prevalence of type 2 diabetes, growing geriatric population, and government initiatives to promote diabetes management are key drivers of the market. However, the adoption of newer anti-diabetic drugs and potential side effects of metformin may restrain the market growth to some extent[2].

Market Analysis for Repaglinide

Market Trends and Projections

The market for repaglinide, while not as expansive as metformin, still holds significant value:

• Market Size and Growth: The global metformin hydrochloride tablet market, which includes repaglinide to some extent, was valued differently in various reports. However, the metformin hydrochloride tablet market specifically is projected to decline at a CAGR of -5.6% from 2025 to 2033, primarily due to the increasing adoption of newer anti-diabetic drugs[2].

• Generic Drugs: Generic versions of metformin and other anti-diabetic drugs, including those similar to repaglinide, are expected to account for a significant market share. This trend is driven by cost-effectiveness and increasing demand in emerging markets[2].

Key Drivers and Restraints

Drivers for Metformin Hydrochloride Market

• Increasing Prevalence of Type 2 Diabetes: The rising number of people living with type 2 diabetes globally is a major driver for the metformin hydrochloride market[1][2][5].

• Government Initiatives: Government programs aimed at promoting diabetes management and awareness contribute to the market growth[2].

• Cardiovascular and Anti-Aging Benefits: The potential benefits of metformin beyond diabetes management, such as cardiovascular health and anti-aging effects, are increasing its appeal and usage[1].

Restraints for Metformin Hydrochloride Market

• Side Effects: Potential side effects like gastrointestinal issues and lactic acidosis can restrain the market growth[2].

• Newer Anti-Diabetic Drugs: The increasing adoption of newer anti-diabetic medications is a significant restraint for the metformin hydrochloride market[2].

Market Segmentation and Competitive Landscape

Market Segmentation

The metformin hydrochloride market is segmented by type, application, and region. Key regions include Asia-Pacific, North America, and Europe, with Asia-Pacific expected to be the largest market due to the high prevalence of diabetes[1][5].

Competitive Landscape

Major players in the metformin hydrochloride market include Wanbury, USV, Shouguang Fukang Pharmaceutical, Vistin Pharma, and others. These companies are analyzed based on their competitive landscape, market positioning, and recent developments[5].

Key Takeaways

• Metformin Hydrochloride: The market is growing due to the increasing prevalence of type 2 diabetes and potential benefits beyond diabetes management. However, it faces restraints from side effects and newer anti-diabetic drugs.

• Repaglinide: While repaglinide remains a viable option for diabetes management, its market is less dynamic compared to metformin hydrochloride, with a projected decline due to the adoption of newer drugs.

• Clinical Trials: Metformin hydrochloride is being extensively studied for its potential in treating multiple sclerosis and other conditions, while repaglinide's clinical trials are less active but still relevant in diabetes management.

FAQs

What is the projected market size for metformin hydrochloride by 2030?

The global metformin hydrochloride market is projected to grow to around USD 386.91 million by 2030[1].

Which region is expected to lead the metformin hydrochloride market?

The Asia-Pacific region is expected to lead the metformin hydrochloride market due to the high prevalence of type 2 diabetes in countries like China and India[1].

What are the potential benefits of metformin beyond diabetes management?

Metformin may offer cardiovascular benefits, slow the aging process, and potentially reduce the risk of cancer, stroke, and dementia[1].

What is the mechanism of action of repaglinide?

Repaglinide stimulates insulin release from the pancreatic β cells in response to meals, reducing postprandial blood glucose levels[3].

Why is the metformin hydrochloride tablet market projected to decline?

The market is projected to decline due to the increasing adoption of newer anti-diabetic drugs and potential side effects associated with metformin[2].

Sources

1. Zion Market Research: Metformin Hydrochloride Market Size, Share and Forecast 2030.
2. Data Insights Market: Metformin Hydrochloride Tablet Unlocking Growth Potential: 2025.
3. DrugBank: Repaglinide: Uses, Interactions, Mechanism of Action.
4. Frontiers in Immunology: A metformin add-on clinical study in multiple sclerosis to evaluate disease progression.
5. QYResearch: Global Metformin Hydrochloride Market Insights, Forecast to 2030.