CLINICAL TRIALS PROFILE FOR AVANDAMET

All Clinical Trials for AVANDAMET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069836 ↗	Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.	Completed	GlaxoSmithKline	Phase 3	2003-10-01	This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.
NCT00110851 ↗	Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)	Completed	Wellstat Therapeutics	Phase 2	2005-04-01	This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).
NCT00116922 ↗	A Lifestyle and Combination Medication Therapy Diabetes Prevention Study	Completed	University of Western Ontario, Canada	Phase 3	2004-06-01	It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.
NCT00116922 ↗	A Lifestyle and Combination Medication Therapy Diabetes Prevention Study	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	Phase 3	2004-06-01	It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.
NCT00131664 ↗	Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)	Completed	GlaxoSmithKline	Phase 3	2005-09-01	The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
NCT00131664 ↗	Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)	Completed	Canadian Heart Research Centre	Phase 3	2005-09-01	The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
NCT00241605 ↗	AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus	Completed	GlaxoSmithKline	Phase 4	2003-06-25	This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.

Clinical Trial Conditions for AVANDAMET

Condition Name

Condition Name for AVANDAMET
Intervention	Trials
Diabetes Mellitus, Type 2	6
Type 2 Diabetes Mellitus	2
Diabetes	2
Breast Cancer	1

Condition MeSH

Condition MeSH for AVANDAMET
Intervention	Trials
Diabetes Mellitus	9
Diabetes Mellitus, Type 2	9
Hyperinsulinism	1
Obesity	1

Clinical Trial Locations for AVANDAMET

Trials by Country

Trials by Country for AVANDAMET
Location	Trials
United States	77
Germany	22
Canada	17
Italy	9
Mexico	8

Trials by US State

Trials by US State for AVANDAMET
Location	Trials
Texas	5
Florida	3
New York	3
South Carolina	3
Pennsylvania	3

Clinical Trial Progress for AVANDAMET

Clinical Trial Phase

Clinical Trial Phase for AVANDAMET
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2	3

Clinical Trial Status

Clinical Trial Status for AVANDAMET
Clinical Trial Phase	Trials
Completed	12
Terminated	1
Unknown status	1

Clinical Trial Sponsors for AVANDAMET

Sponsor Name

Sponsor Name for AVANDAMET
Sponsor	Trials
GlaxoSmithKline	8
Brooke Army Medical Center	1
Wellstat Therapeutics	1

Sponsor Type

Sponsor Type for AVANDAMET
Sponsor	Trials
Industry	10
Other	10
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Avandamet

Last updated: October 30, 2025

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Introduction

Avandamet, a combination drug comprising rosiglitazone maleate and metformin hydrochloride, is employed primarily in managing type 2 diabetes mellitus. As the landscape of antidiabetic therapies evolves, understanding Avandamet's clinical trial landscape, market positioning, and future projections is critical for stakeholders ranging from pharmaceutical companies to healthcare providers.

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Clinical Trials Update

Overview of Clinical Development

Originally developed by GlaxoSmithKline (GSK), Avandamet was introduced following extensive clinical validation demonstrating efficacy in glycemic control. Its clinical trials concentrated on combination therapy advantages, such as improved glycemic regulation and reduced progression of diabetes-related complications.

Recent Clinical Trials and Research Focus

In recent years, there has been limited active clinical trial activity explicitly centered on Avandamet. The primary reason relates to concerns surrounding rosiglitazone’s cardiovascular safety profile, which led regulatory authorities like the FDA to restrict its use in 2013. Consequently, most clinical research has pivoted toward other thiazolidinediones or alternative mechanisms.

However, some ongoing and retrospective observational studies are investigating the long-term safety and efficacy of rosiglitazone-based treatments, including Avandamet, particularly focusing on cardiovascular outcomes, safety in special populations (e.g., renal impairment), and combination therapy advantages. Notably, a retrospective study published in Diabetes Care indicated that certain formulations, including Avandamet, continue to be utilized in specific markets under regulatory oversight, especially where alternatives are limited.

Regulatory Status and Global Approvals

Globally, Avandamet’s market authorization remains valid in some countries outside the United States, notably in certain Latin American and Asian markets. Meanwhile, in regions like the European Union and the US, its use has declined substantially following safety concerns with rosiglitazone. Regulatory agencies have imposed restrictions, emphasizing post-market surveillance.

Innovation and Future Trials

Given its historical profile, the likelihood of new clinical trials for Avandamet is limited. The focus has shifted toward newer agents such as SGLT2 inhibitors and GLP-1 receptor agonists, which offer better safety profiles and additional benefits. Nevertheless, in regions with limited access to newer medications, Avandamet's clinical utility may persist, especially if safety concerns are addressed.

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Market Analysis

Historical Market Position

At its peak, Avandamet represented an important segment in combination antidiabetic formulations. The combination aimed to optimize glycemic control, decrease pill burden, and improve patient compliance. It was particularly prevalent in markets with slower adoption of newer agents and where affordability played a role.

Market Decline Post-Safety Concerns

The cardiovascular safety issues associated with rosiglitazone significantly dampened Avandamet’s market penetration. Following the FDA’s restrictions and subsequent withdrawals, sales plummeted in North America and Europe. For example, GSK's global sales of rosiglitazone-containing products declined from hundreds of millions annually pre-2010 to negligible levels thereafter [1].

Current Market Dynamics

Today, Avandamet maintains a niche presence primarily in emerging markets. Several factors influence its market status:

• Regulatory Restrictions: Stringent safety regulations restrict access in developed markets.
• Generic Availability: Generic formulations are available in some regions, potentially lowering costs but also limiting the incentive for innovation.
• Competition: The market is saturated with newer agents—SGLT2 inhibitors (e.g., empagliflozin) and GLP-1 receptor agonists (e.g., liraglutide)—which offer superior safety and additional benefits like weight loss and cardiovascular protection [2].

Market Forecast

Despite setbacks, the global diabetes medication market is projected to grow from USD 85.8 billion in 2022 to USD 118.3 billion by 2027, exhibiting a CAGR of approximately 6.7% [3]. Within this paradigm, Avandamet is expected to decline further in developed markets but remain relevant in regions with limited access to newer therapies.

In Latin America, Asia-Pacific, and Africa, the demand for affordable, effective antidiabetic drugs sustains a moderate plateau for older combination formulations. If regulatory hurdles are mitigated, and safety concerns addressed, Avandamet could see a minor resurgence, especially if patents expire, enabling cost-competitive generics.

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Market Projection

Short-Term Outlook (1–3 years)

The short-term outlook remains cautious. Regulatory restrictions and safety concerns will keep Avandamet's presence limited mainly to existing patients and specific markets. Market share is expected to decline sharply in North America and Europe but stabilize in select emerging markets.

Medium to Long-Term Outlook (3–10 years)

Long-term projections depend heavily on regulatory developments and safety profile reassessment. If Avandamet formulations are reformulated or safety data support expanded use, modest growth could occur in low- and middle-income economies. Otherwise, incremental decline is anticipated, supplanted mainly by newer agents with demonstrated cardiovascular and metabolic benefits.

Key Market Players

Major pharmaceutical companies involved in older antidiabetic medications include GSK (legacy products), Novartis, and generic manufacturers in emerging markets. Companies investing in novel drug platforms may shift focus away from Avandamet, favoring innovation over legacy formulations.

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Summary of Market Opportunities and Challenges

Opportunities:

• Keep presence in markets with limited access to newer agents.
• Potential reformulation or safety profile improvements.
• Cost-effective alternative in resource-limited settings.

Challenges:

• Regulatory restrictions due to safety issues.
• Competitive landscape dominated by newer, safer drugs.
• Limited clinical trial activity, reducing innovation prospects.

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Key Takeaways

• Clinical development for Avandamet has stagnated, largely due to safety concerns surrounding rosiglitazone, impacting its global clinical appeal.
• Market presence persists mainly in emerging economies, where affordability and limited alternatives sustain demand.
• Regulatory restrictions have significantly curtailed its use in developed regions, with future prospects hinging on safety profile re-evaluation.
• The innovative landscape favors newer therapies, placing Avandamet at a structural disadvantage for market growth.
• Strategic opportunities exist in low-resource settings, contingent upon reformulation and safety re-affirmation.

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FAQs

1. Why did Avandamet's global market decline significantly after 2010?
Safety concerns linked to rosiglitazone's cardiovascular risks led regulatory agencies like the FDA to impose restrictions, resulting in decreased sales and market withdrawal in many regions.

2. Are there ongoing clinical trials for Avandamet?
Currently, active clinical trial activity specifically for Avandamet is minimal. Most research focuses on newer antidiabetic agents or retrospective safety evaluations of rosiglitazone.

3. Can Avandamet be safely used today?
In certain markets, under strict regulatory oversight and with appropriate patient monitoring, Avandamet remains accessible. However, safety concerns necessitate cautious use, especially given the cardiovascular risks associated with rosiglitazone.

4. What is the future of Avandamet in the global market?
Its future is limited to niche markets and resource-limited settings. Market share will likely decline further unless safety issues are addressed or reformulations are introduced.

5. How does Avandamet compare to newer diabetes medications?
Newer agents like SGLT2 inhibitors and GLP-1 receptor agonists offer better safety profiles, additional metabolic benefits, and cardiovascular protection, making them more favorable options in developed markets.

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References

[1] “Rosiglitazone and Cardiovascular Risk,” U.S. Food and Drug Administration, 2013.
[2] “Global Diabetes Drugs Market Report,” MarketsandMarkets, 2022.
[3] “Diabetes Medication Market Analysis,” Grand View Research, 2023.