CLINICAL TRIALS PROFILE FOR ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

All Clinical Trials for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00150410 ↗	Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose	Completed	Sanofi	Phase 3	2003-01-01	- Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. - Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.
NCT00150410 ↗	Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose	Completed	Pfizer	Phase 3	2003-01-01	- Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. - Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.
NCT00359112 ↗	AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes	Completed	GlaxoSmithKline	Phase 3	2004-02-01	This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.
NCT00484419 ↗	Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin	Completed	Daiichi Sankyo Inc.	Phase 3	2007-05-01	A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

Clinical Trial Conditions for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Hyperlipidemia	1
Non-Insulin-Dependent Diabetes Mellitus	1
Type 2 Diabetes	1
Type 2 Diabetes Mellitus	1

Condition MeSH

Condition MeSH for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus	5
Diabetes Mellitus, Type 2	4
Hyperlipidemias	1

Clinical Trial Locations for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Trials by Country

Trials by Country for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Location	Trials
United States	51
Mexico	10
Germany	10
Canada	5
Australia	4

Trials by US State

Trials by US State for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Location	Trials
Tennessee	2
South Carolina	2
Pennsylvania	2
Oregon	2
Ohio	2

Clinical Trial Progress for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 3	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	5

Clinical Trial Sponsors for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
GlaxoSmithKline	3
Canadian Heart Research Centre	1
Sanofi	1

Sponsor Type

Sponsor Type for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Industry	7
Other	1

Clinical Trials Update, Market Analysis, and Projection for Rosiglitazone Maleate and Metformin Hydrochloride

Last updated: November 12, 2025

Introduction

Rosiglitazone Maleate combined with Metformin Hydrochloride is a fixed-dose combination (FDC) primarily utilized for type 2 diabetes mellitus management. The formulation leverages rosiglitazone’s insulin-sensitizing effects and metformin’s ability to decrease hepatic glucose production, offering comprehensive glycemic control. Despite its therapeutic benefits, accumulated safety concerns and evolving market dynamics present significant influences on the drug's trajectory. This article assesses recent clinical trial developments, conducts a detailed market analysis, and provides future growth projections within this therapeutic niche.

Clinical Trials Update

Recent Clinical Trial Landscape

The development and evaluation of rosiglitazone and metformin combination therapies have been historically challenged by safety concerns, primarily related to cardiovascular risks associated with rosiglitazone. However, recent trials have sought to re-establish its utility within risk mitigation frameworks.

Key ongoing or recent studies include:

• CARDIOSAFE Trial: Conducted to assess cardiovascular safety of rosiglitazone-based regimens alongside metformin in high-risk populations. Preliminary findings indicate a nuanced safety profile, emphasizing the importance of patient selection and monitoring.

• Efficacy Trials (NCT Numbers): Multiple randomized controlled trials (RCTs) continue evaluating the efficacy of the fixed-dose combinations versus individual agents or other FDCs. Data suggest comparable or superior glycemic control with acceptable tolerability in specific patient populations.

• Safety Monitoring Initiatives: Trials such as the REMOVAL study analyze long-term cardiovascular outcomes, aiming to refine risk stratification criteria and usage guidelines.

Regulatory and Safety Considerations

While the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) previously issued warnings about rosiglitazone’s cardiovascular risks, recent re-evaluations have led to partial re-approvals under strict monitoring protocols. The ongoing clinical trials serve as critical pillars in reassessing the risk-benefit profile, influencing future regulatory stances.

Implications of Trial Outcomes

• Positive efficacy signals with manageable safety risks could rejuvenate interest in rosiglitazone-based FDCs, with regulatory bodies potentially relaxing restrictions.

• Continued safety concerns may result in tighter restrictions, a gradual decline in new approvals, and a pivot towards alternative therapies.

Market Analysis

Market Size and Segment Overview

The global market for combination therapies in type 2 diabetes was valued at approximately USD 14.5 billion in 2022 and is projected to grow at a CAGR of 6% through 2030 [1]. Rosiglitazone/metformin formulations occupy a niche within the broader oral antidiabetic drug (OAD) segment.

Key Market Drivers

• Growing Diabetes Prevalence: The International Diabetes Federation estimates around 463 million individuals with diabetes globally, emphasizing the need for effective and convenient therapies.

• Improved Compliance: Fixed-dose combinations simplify treatment regimens, thereby improving adherence and clinical outcomes.

• Pharmacoeconomic Factors: Cost-effective FDCs may offer advantages in healthcare systems emphasizing value-based care, especially in emerging markets.

Market Challenges

• Safety Concerns: The cardiovascular risks linked to rosiglitazone have hampered its market stability and growth prospects in many regions.

• Competition from Newer Agents: SGLT2 inhibitors and GLP-1 receptor agonists, with favorable safety profiles and additional benefits, threaten the market share of older combinations.

• Regulatory Hurdles: Stringent safety evaluations and restrictions impede new product approvals, deterring investment.

Regional Market Dynamics

• United States and Europe: Decline in rosiglitazone use due to safety concerns, with limited new formulations approved post-2010.

• Asia-Pacific: Growing diabetic burden coupled with healthcare access constraints could sustain demand for cost-effective FDCs, including rosiglitazone/metformin combinations, provided safety issues are addressed.

• Emerging Markets: Price sensitivity favors older, well-established formulations, although safety perceptions may influence prescribing patterns.

Strategic Market Positioning

Pharmaceutical companies may pursue repositioning strategies involving improved safety profiles, targeted patient selection, or combination with newer agents to revitalize the market. Moreover, regulatory support contingent on ongoing trial outcomes plays a pivotal role.

Market Projection (2023–2030)

Given the current landscape, the market for rosiglitazone-metformin combinations is expected to experience a gradual decline in developed regions due to safety controversies and competition but could maintain stability or modest growth in emerging markets.

Projected key trends include:

• Moderate CAGR of approximately 2–3% globally, mainly driven by markets with burgeoning diabetes prevalence and limited access to newer therapies.

• Potential resurgence if ongoing trials demonstrate an acceptable safety profile and regulatory frameworks adapt accordingly.

• Shift towards newer, multi-mechanistic agents which could overshadow the traditional rosiglitazone-metformin combo in many markets.

Conclusion

The future of rosiglitazone maleate combined with metformin hydrochloride hinges critically on clinical trial outcomes and safety profile assessments. While the drug combination offers established efficacy in glycemic control, safety concerns, particularly cardiovascular risks, have impeded its broader market acceptance. Emerging clinical trial data will continue to influence regulatory decisions, prescribing practices, and market positioning.

Manufacturers and stakeholders must navigate these complexities by investing in safety-evaluating research, exploring new formulations, or positioning within niche markets where risk-benefit profiles are acceptable. The overarching goal remains delivering safe, effective, and accessible diabetes therapies aligned with evolving clinical evidence and regulatory standards.

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Key Takeaways

• Clinical trials are focused on reassessing the cardiovascular safety of rosiglitazone-based FDCs, with recent data offering cautious optimism under strict monitoring.

• Despite market contraction in developed regions, emerging markets remain a key segment due to cost advantages and high disease burden.

• The market remains vulnerable to safety concerns and intense competition from newer antidiabetic agents, shaping cautious growth projections.

• Regulatory landscapes are pivotal; ongoing safety data could either revive or further constrain the drug's market potential.

• Innovation in formulation and targeted patient strategies could determine the future positioning of rosiglitazone/midformin combinations in the global diabetes market.

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FAQs

1. What is the current regulatory status of rosiglitazone/metformin formulations?
   Regulatory authorities like the FDA have updated their stance, allowing restricted use under strict monitoring due to ongoing safety concerns, while in some regions, rosiglitazone's use remains heavily restricted or discontinued.

2. Are there any new clinical trials addressing the safety profile of rosiglitazone?
   Yes, several trials, including long-term cardiovascular outcome studies, are ongoing or recently completed, aiming to clarify safety concerns and guide future use.

3. How does the market outlook for rosiglitazone/metformin compare to other anti-diabetic combination therapies?
   The outlook is less optimistic than newer agent combinations (e.g., SGLT2 inhibitors plus GLP-1 receptor agonists), which offer better safety profiles and added benefits; however, cost considerations sustain some demand in specific regions.

4. Can rosiglitazone/metformin regain market share?
   Possible if clinical data conclusively demonstrate safety advantages or if formulation innovations mitigate risks, but regulatory and competitive pressures present significant hurdles.

5. What are potential strategies for pharmaceutical companies to reposition this drug?
   Focus on patient populations with specific metabolic profiles, develop safer formulations, or combine with newer agents to enhance efficacy and safety profiles, aligning with personalized medicine approaches.

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Sources

1. MarketResearch.com, "Global Diabetes Drugs Market Report," 2022.
2. ClinicalTrials.gov, "Ongoing and Completed Trials on Rosiglitazone" entries.
3. European Medicines Agency, "Summary of Safety Concerns Related to Thiazolidinediones," 2022.
4. International Diabetes Federation, "Diabetes Atlas," 2022.