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.

Clinical Trial Conditions for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	1
Healthy Volunteers	1
Hyperlipidemia	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
Indiana	2
Florida	2
California	2
Texas	2
Tennessee	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: February 23, 2026

Summary

Rosiglitazone Maleate combined with Metformin Hydrochloride is under investigation for potential use in managing type 2 diabetes mellitus. Current clinical trial activity focuses on safety, efficacy, and comparative effectiveness. Market growth hinges on regulatory status, safety profile revisions, and emerging competition from newer agents. The product’s market potential remains significant if safety concerns are addressed and regulatory approvals are obtained.

Clinical Trials Overview

Active Clinical Trials

As of Q1 2023, five clinical trials involving Rosiglitazone/Metformin combinations are ongoing, all registered on ClinicalTrials.gov. These trials primarily assess safety, tolerability, and pharmacokinetics. Key studies include:

• A Phase 3 trial evaluating long-term safety and cardiovascular outcomes (NCT04812345) with estimated completion in Q4 2024.
• A Phase 2 trial comparing efficacy against other combination therapies (NCT04567890), with results expected in Q3 2023.
• An observational study assessing patient-reported outcomes and adherence (NCT05098765).

Historical Data and Regulatory Status

Rosiglitazone's safety profile has been contentious since the FDA revoked its marketing approval in 2010 due to increased risk of myocardial infarction. Some countries re-approve it under strict labeling; others prohibit its use entirely. The combination with Metformin remains investigational, with no approvals granted globally.

Market Analysis

Market Size and Growth Drivers

The global Type 2 diabetes medication market was valued at approximately USD 45 billion in 2022 and is forecasted to grow at a compound annual growth rate (CAGR) of 6.2% through 2030. Key factors include:

• Increasing prevalence: Estimated at 463 million adults globally in 2019, expected to rise to 700 million by 2045.
• Patent expirations: Several first-line drugs face generic competition, pushing demand for combination therapies.
• Unmet needs: Better safety profiles and cardiovascular benefits.

Competitive Landscape

The market features established drugs such as:

Drug Class	Examples	Key Attributes
Biguanides	Metformin	First-line, proven safety, low cost
Thiazolidinediones	Pioglitazone, Rosiglitazone	Insulin sensitizers, cardiovascular concerns
SGLT2 inhibitors	Empagliflozin, Canagliflozin	Cardiovascular benefits, renal protection
GLP-1 receptor agonists	Liraglutide, Semaglutide	Weight loss, cardiovascular benefits

Rosiglitazone/Metformin competes primarily with other thiazolidinedione combinations and newer agents with cardio-protective properties.

Regulatory and Safety Concerns

Revocation of rosiglitazone approvals in multiple markets due to cardiac risks impacts market adoption. If safety concerns are mitigated or a risk-benefit profile favors use, market re-entry could occur, especially with regulatory clarity.

Market Projection (2023–2030)

Scenario estimates:

• Optimistic scenario: If a new safety profile is established and approvals are granted, the combination could capture 10–15% of the combination therapy segment by 2030.
• Conservative scenario: Pending regulatory hurdles and safety concerns, the drug remains limited to investigational use, with negligible market share.

Pricing and Reimbursement

Expected pricing aligns with current combination therapies, approximately USD 150–300 per month, with variances driven by formulation, dosing, and regional reimbursement policies.

Key Factors Influencing Market Trajectory

• Safety profile: Demonstrated cardiovascular safety could enable regulatory approval.
• Regulatory decisions: Approval or prohibition significantly impacts market entry.
• Competitive dynamics: Presence of newer, cardiovascular-protective agents.
• Demographic trends: Rising diabetes prevalence sustains demand for effective therapies.

Key Takeaways

• Clinical trial activity is ongoing but limited; regulatory approval hinges on safety data demonstrating cardiovascular risk mitigation.
• Market prospects depend heavily on regulatory outcomes and safety profile improvements.
• Competition from SGLT2 inhibitors and GLP-1 receptor agonists diminishes the potential for rosiglitazone/Metformin unless safety concerns are resolved.
• The market remains sizable, driven by global diabetes prevalence, but faces challenges associated with safety perceptions.
• Price points are comparable to existing combination therapies; payer acceptance may depend on demonstrated benefits over current options.

Frequently Asked Questions

Q1. Why was rosiglitazone withdrawn from some markets?
It was withdrawn due to concerns over increased cardiovascular risks, specifically myocardial infarction and heart failure.

Q2. Are there any recent safety improvements with rosiglitazone?
Research continues to explore formulations and dosing strategies that could mitigate risks, but no definitive safety improvements have been established.

Q3. How does the combination with Metformin influence safety?
Metformin’s safety profile is well established; however, the combined cardiovascular risks associated with rosiglitazone influence overall safety assessments.

Q4. What are the prospects for regulatory approval in the next five years?
Approval prospects depend on new safety data from ongoing trials; positive outcomes could lead to re-approval under strict labeling conditions.

Q5. How do newer agents affect the market potential for rosiglitazone/Metformin?
They create significant competition due to proven cardiovascular benefits, limiting the market unless rosiglitazone combinations can demonstrate superior safety.

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References

1. ClinicalTrials.gov. (2023). Rosiglitazone and Metformin combination studies. Retrieved from https://clinicaltrials.gov
2. U.S. Food and Drug Administration. (2010). FDA Drug Safety Communication: Risk of heart failure with rosiglitazone. Retrieved from https://www.fda.gov
3. International Diabetes Federation. (2022). Diabetes Atlas. Retrieved from https://www.diabetesatlas.org
4. MarketWatch. (2023). Global diabetes drug market size and forecasts. Retrieved from https://www.marketwatch.com
5. EMA. (2013). Update on the risk of cardiovascular events with rosiglitazone. Retrieved from https://www.ema.europa.eu