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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR FORTAMET


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All Clinical Trials for Fortamet

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00087516 ↗ Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021) Completed Merck Sharp & Dohme Corp. Phase 3 2004-06-01 The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
NCT00344851 ↗ Exenatide and Metformin Therapy in Overweight Women With PCOS Completed Amylin Pharmaceuticals, LLC. Phase 2 2006-06-01 Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.
NCT00344851 ↗ Exenatide and Metformin Therapy in Overweight Women With PCOS Completed Metabolic Center of Louisiana Research Foundation Phase 2 2006-06-01 Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.
NCT00443755 ↗ Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance Completed National Center for Research Resources (NCRR) Phase 2 2005-08-01 The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
NCT00443755 ↗ Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2005-08-01 The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
NCT00443755 ↗ Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance Completed Takeda Pharmaceuticals North America, Inc. Phase 2 2005-08-01 The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
NCT00443755 ↗ Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance Completed Mayo Clinic Phase 2 2005-08-01 The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fortamet

Condition Name

Condition Name for Fortamet
Intervention Trials
Type 2 Diabetes 5
Insulin Resistance 5
Type 2 Diabetes Mellitus 4
Diabetes 3
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Condition MeSH

Condition MeSH for Fortamet
Intervention Trials
Diabetes Mellitus 13
Diabetes Mellitus, Type 2 9
Insulin Resistance 6
Metabolic Syndrome X 4
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Clinical Trial Locations for Fortamet

Trials by Country

Trials by Country for Fortamet
Location Trials
United States 105
China 17
Mexico 4
South Africa 4
Canada 4
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Trials by US State

Trials by US State for Fortamet
Location Trials
Ohio 6
North Carolina 6
New York 6
California 5
Massachusetts 5
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Clinical Trial Progress for Fortamet

Clinical Trial Phase

Clinical Trial Phase for Fortamet
Clinical Trial Phase Trials
Phase 4 13
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Fortamet
Clinical Trial Phase Trials
Completed 21
Recruiting 7
Terminated 6
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Clinical Trial Sponsors for Fortamet

Sponsor Name

Sponsor Name for Fortamet
Sponsor Trials
Takeda 5
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 5
Merck Sharp & Dohme Corp. 4
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Sponsor Type

Sponsor Type for Fortamet
Sponsor Trials
Other 44
Industry 23
NIH 15
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Clinical Trials, Market Analysis, and Projections for Fortamet (Metformin Hydrochloride Extended-Release Tablets)

Introduction to Fortamet

Fortamet, a brand of metformin hydrochloride extended-release tablets, is widely used in the management of type 2 diabetes mellitus. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Comparison with Immediate-Release Metformin

Clinical trials have compared the efficacy and pharmacokinetics of Fortamet with immediate-release metformin. A key study involved 23 patients with type 2 diabetes who were administered either Fortamet 2000 mg once daily or immediate-release metformin 1000 mg twice daily. The results showed that the steady-state pharmacokinetic parameters, including area under the concentration-time curve (AUC), time to peak plasma concentration (Tmax), and maximum concentration (Cmax), were similar between the two formulations. This indicates that patients can be safely switched from immediate-release metformin to Fortamet once daily without significant changes in pharmacokinetic profiles[1][4].

Non-Inferiority Study

A larger study aimed to demonstrate the clinical non-inferiority of Fortamet compared to immediate-release metformin. This double-blind study involved patients who were randomly assigned to either Fortamet or immediate-release metformin. The primary efficacy endpoint was the change in HbA1c from baseline to endpoint. The results showed that both formulations had similar effects on HbA1c levels, with Fortamet demonstrating clinical similarity to immediate-release metformin. However, the study also noted that the response to Fortamet was statistically smaller, although not clinically meaningful[1].

Safety and Tolerability

The studies also evaluated the safety and tolerability of Fortamet. It was observed that neither Fortamet nor immediate-release metformin were associated with weight gain or increases in body mass index. However, more patients on Fortamet discontinued the trial due to a lack of efficacy compared to those on immediate-release metformin[1].

Market Analysis

Current Market Size and Growth

The global metformin market, which includes both standard-release and extended-release formulations like Fortamet, was valued at USD 4,028 million in 2022. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.0% to reach USD 6,420.02 billion by 2030[2].

Segmentation and Distribution

The market is segmented by product type (standard-release tablets and slow-release tablets), dosage type (500mg, 750mg, 850mg, and 1g), end-users (clinics, hospitals, homecare, and others), and distribution channels (hospital pharmacy, retail pharmacy, online pharmacy, and others). The extended-release tablets, such as Fortamet, are gaining traction due to their convenience and once-daily dosing regimen[2][5].

Key Players and Market Dynamics

The metformin market is competitive, with several major players. The market dynamics are influenced by factors such as patient epidemiology, pipeline analysis, pricing analysis, and regulatory frameworks. The COVID-19 pandemic has also impacted the market, leading to changes in market dynamics and growth opportunities[2][5].

Projections and Future Outlook

Market Growth Drivers

The growth of the metformin market, including Fortamet, is driven by several factors:

  • Increasing prevalence of type 2 diabetes globally.
  • Advantages of extended-release formulations, such as improved patient compliance and reduced gastrointestinal side effects.
  • Expanding distribution channels, including online pharmacies.
  • Continuous research and development in diabetes management[2][5].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as:

  • Competition from generic metformin products.
  • Regulatory hurdles and pricing pressures.
  • Need for continuous innovation to stay competitive.

However, there are also opportunities for growth, particularly in emerging markets and through strategic partnerships and product launches[2][5].

Pharmacokinetics and Clinical Implications

Pharmacokinetic Parameters

Fortamet exhibits a slower and more prolonged appearance in plasma compared to immediate-release metformin. The AUC, Tmax, and Cmax of Fortamet are similar to those of immediate-release metformin when administered in equivalent doses. This pharmacokinetic profile supports the once-daily dosing regimen of Fortamet[1][4].

Clinical Implications

The pharmacokinetic similarity between Fortamet and immediate-release metformin allows for safe switching between the two formulations. This is particularly beneficial for patients who may prefer a once-daily regimen, potentially improving adherence to treatment. Additionally, the lack of significant weight gain or increase in body mass index makes Fortamet a favorable option for long-term diabetes management[1].

Conclusion

Fortamet, as an extended-release formulation of metformin, has demonstrated clinical efficacy and safety in managing type 2 diabetes. The market for metformin, including Fortamet, is expected to grow significantly over the next few years, driven by increasing demand and the advantages of extended-release formulations. However, the market also faces challenges that need to be addressed through continuous innovation and strategic market positioning.

Key Takeaways

  • Clinical Efficacy: Fortamet is clinically similar to immediate-release metformin in managing type 2 diabetes.
  • Market Growth: The global metformin market is projected to grow at a CAGR of 6.0% from 2022 to 2030.
  • Pharmacokinetics: Fortamet has a slower and more prolonged appearance in plasma, supporting once-daily dosing.
  • Safety and Tolerability: Fortamet does not lead to significant weight gain or increases in body mass index.
  • Market Dynamics: The market is influenced by patient epidemiology, regulatory frameworks, and distribution channels.

FAQs

What is the primary advantage of Fortamet over immediate-release metformin?

The primary advantage of Fortamet is its once-daily dosing regimen, which can improve patient compliance and reduce gastrointestinal side effects.

How does the pharmacokinetic profile of Fortamet compare to immediate-release metformin?

The pharmacokinetic parameters of Fortamet, including AUC, Tmax, and Cmax, are similar to those of immediate-release metformin when administered in equivalent doses, but with a slower and more prolonged appearance in plasma[1][4].

What are the key drivers of the global metformin market growth?

The growth is driven by the increasing prevalence of type 2 diabetes, advantages of extended-release formulations, expanding distribution channels, and continuous research and development in diabetes management[2][5].

Are there any significant safety concerns associated with Fortamet?

Fortamet is generally safe and does not lead to significant weight gain or increases in body mass index. However, it may need to be discontinued during iodinated contrast imaging procedures and is contraindicated in patients with severe renal impairment[1][4].

What is the projected market size of the global metformin market by 2030?

The global metformin market is projected to reach USD 6,420.02 billion by 2030, growing at a CAGR of 6.0% from 2022[2].

Sources

  1. FORTAMET® (metformin hydrochloride) Extended-Release Tablets - FDA Label[1].
  2. Global Metformin Market Size, Share, Statistics & Industry Forecast By 2030 - Data Bridge Market Research[2].
  3. Sagimet Biosciences Announces Publication of Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat - Sagimet Biosciences (Note: This source is not directly related to Fortamet but provides context on other diabetes-related treatments)[3].
  4. FORTAMET - Shionogi Inc. - Shionogi Inc.[4].
  5. Metformin Hydrochloride Market Analysis, Industry Size, Share ... - Biospace[5].

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